A 510(k) on a Thread Is Not an Automatic Lift Identity
When a clinic offers a named absorbable-thread lift, the brochure may say 'FDA-cleared.' That phrase does not mean FDA evaluated a facelift, reviewed trials proving that every PDO thread lifts jowls, or granted official approval. This page did not census clinic advertisements, so it does not estimate how often that slogan appears. The identity question is narrower: which 510(k) sentence belongs to the packet in the room?
Under United States law, medical devices are not granted generic blanket endorsements. Every 510(k) clearance is tied to the indications-for-use statement in that submission. A device cleared as an absorbable surgical suture is cleared to approximate soft tissue where that IFU says so. It is not automatically indicated for mid-face suspension or for lifting and supporting tissues.
The named packets on this page reached U.S. commercial distribution through Premarket Notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act. FDA's Premarket Notification 510(k) page states that a 510(k) demonstrates that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device, and that FDA's order finding substantial equivalence 'clears' the device for commercial distribution. That is not PMA approval, and it is not a finding that the device permanently resolves a cosmetic condition.
21 CFR 807.97 states that submission of a premarket notification and a subsequent substantial-equivalence determination does not in any way denote official approval of the device. Any representation that creates an impression of official approval of a device because of complying with the premarket-notification regulations is misleading and constitutes misbranding. Calling a 510(k)-cleared thread an 'FDA-approved lift' is that kind of representation.
21 CFR 807.92(a)(5) requires a 510(k) summary to include a statement of the intended use of the device, including a general description of the diseases or conditions the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If those indication statements differ from the identified predicate, the summary must explain why the differences are not critical to intended use and do not affect safety and effectiveness when used as labeled. The public identity field for this article is that indications-for-use sentence on the 510(k) summary and Form FDA 3881, not a clinic slogan.
This page classifies the named packet's 510(k) identity. It does not give insertion, depth, vector, or dosing instructions. It is deliberately distinct from clinical complication reviews (Thread Lift Complications: Risks, Frequency, and Future Facelift Concerns), clinical longevity analyses (covered in our Thread Lift Evidence: How Well It Works and How Long It Lasts), generic 510(k) verification mechanics (see Is That Aesthetic Device FDA-Cleared? How to Verify Any Machine (and Why CE Doesn't Count)), off-label risk disclosures (see Off-Label Aesthetic Treatment Consent: Documenting Risk Clearly), and medical record requests (see Requesting Aesthetic Records: Device Settings, Lot Numbers, and Limits). Instead, this article answers one essential question: when you look at a named packet today, which 510(k) identity actually applies?
It is also not a retitle of the 510(k) pathway explainer (How Aesthetic Devices Get FDA Clearance — The 510(k) Process Explained), the cleared-versus-registered buyer framework (FDA-Cleared or Just FDA-Registered? Verifying Aesthetic Device Claims With DJ Fang), or the laxity-option pages that mention threads without this indication split (Non-surgical facelift devices: what tightens, what lifts, what cannot replace surgery.; How to Get Rid of Jowls Without Surgery — and When Only a Facelift Will Work; Facelift Surgery Guide: SMAS vs Deep Plane, Cost, Recovery, and ASPS Trends; Will Filler Affect a Future Facelift? What Surgeons See and What Patients Should Ask).
The Four Regulatory Identities for One Named Packet
Copy the indications-for-use sentence that belongs to the named packet, then classify that one packet into one of four identity buckets. The buckets are a reading order, not a finding that two packets are interchangeable. Extra advertising is a separate intended-use field; it does not rewrite the 510(k) sentence:
Identity 1: 510(k)-Cleared Absorbable Suture with Explicit No-Lift Restriction. The device holds a valid 510(k) clearance under 21 CFR 878.4840 as an absorbable surgical suture. However, its cleared indications for use are strictly limited to soft-tissue wound approximation and contain an explicit, unambiguous restriction stating that the suture is not intended for lifting and supporting tissues.
Identity 2: 510(k)-Cleared Suspension Device for Cheek Subdermis Fixation. The device holds a valid 510(k) clearance with an affirmative indications-for-use statement authorizing mid-face or face suspension surgery to temporarily fixate the cheek subdermis (or cheek subcutaneous fat and superficial musculoaponeurotic system / SMAS) in an elevated position.
Identity 3: Suture Clearance with Marketing Claims Beyond the Cleared Indication. The device holds a valid 510(k) clearance limited strictly to soft-tissue approximation, but manufacturer marketing, distributor sales copy, or clinic advertising actively promotes the product for mechanical lifting, skin tightening, or tissue volumizing without obtaining an updated 510(k) clearance for those cosmetic intended uses.
Identity 4: Unidentified or Unverified Medical Device. The sterile packaging, clinic consent documentation, or provider records fail to identify a valid 510(k) premarket notification number, or the trade name printed on the blister pack cannot be cross-referenced to any substantial-equivalence determination in the public FDA database.
A common confusion is conflating polymer chemistry with clearance scope. Polydioxanone (PDO) is classified under 21 CFR 878.4840. Silhouette InstaLift is classified under 21 CFR 878.4493. The K163676 device description states that both the monofilament and the cones are made from L-lactide/glycolide bioresorbable resin, not polydioxanone. Subsequent product code GAM on a later PDO 510(k) does not convert that PDO packet into Silhouette InstaLift.
Knowing that a thread is made of polydioxanone identifies a polymer family under 21 CFR 878.4840. It does not tell you whether that packet's indications-for-use sentence is limited to soft-tissue approximation, includes mid-face or face suspension, or is unidentified. PDO products exist in Identity 1, Identity 2, and Identity 3. How long a polymer remains in tissue, and how long any visible lift lasts, is a durability question for the existing evidence article, not an identity field on this page.
Soft-Tissue Approximation IFUs That Explicitly Exclude Lifting
The foundational regulation governing polydioxanone in medical devices is 21 CFR 878.4840. The regulation classifies an absorbable polydioxanone surgical suture as a Class II medical device subject to special controls. The regulation identifies the device as a flexible, sterile monofilament thread prepared from the polyester polymer poly(p-dioxanone) and indicated for use in soft tissue approximation, including pediatric cardiovascular tissue and ophthalmic surgery.
Under product code NEW, numerous manufacturers have obtained 510(k) clearances for PDO sutures marketed to aesthetic practitioners. However, when examining the actual decision letters and 510(k) summaries, a striking pattern emerges: several prominent product families carry an explicit, affirmative disclaimer forbidding lifting claims.
PDO Max Suture with Dual Needle (K210871): In the 510(k) summary cleared by the FDA on December 17, 2021, the device is classified under 21 CFR 878.4840, product code NEW. The official Indications for Use statement reads:
"The PDO Max Suture with Dual Needle is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues."
This four-part formulation is not an informal footnote. It is the legally binding boundary of the device's substantial equivalence determination. The clearance authorizes the device to hold skin edges together in dermatological wound closure; it explicitly bars the manufacturer from intending the device for lifting and supporting tissues.
PDS Barbed Suture / PDO MAXX Threads (K190245): An earlier PDO MAX, Inc. clearance, dated June 4, 2019, under 21 CFR 878.4840, product code NEW, uses the same four-part boundary: indicated for soft-tissue approximation, restricted to dermatological skin applications, excluded from interior body cavities, and explicitly "not intended for lifting and supporting tissues."
Secret Line up and i-Thread (K242571): This restrictive phrasing is not a legacy artifact from earlier regulatory eras. On September 27, 2024, FDA cleared K242571 for Secret Line up and i-Thread under 21 CFR 878.4840, product code NEW. Its official Indications for Use statement reaffirms the exact same restriction:
"Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. The suture is not intended for body cavity applications, nor is it intended for lifting and supporting tissues; it is intended for dermatological use only."
Those no-lift sentences are the legally binding boundary of those substantial-equivalence determinations. Classification as product code NEW under 21 CFR 878.4840 is a suture-family identity: an absorbable, flexible, sterile, monofilament thread prepared from poly(p-dioxanone) and intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. Individual 510(k) IFUs can be narrower. K210871, K190245, and K242571 add dermatological-only limits and an express bar on lifting and supporting tissues. That classification is not, by itself, an indication for mid-face suspension.
This page does not infer why a sponsor accepted a no-lift clause, and it does not inventory clinic technique. If a packet carries one of those IFU sentences, Identity 1 still applies even when the appointment is sold as a lift.
Suspension Indications: Cheek Subdermis Fixation and Mid-Face Claims
In contrast to Identity 1, a select group of absorbable thread products have submitted the clinical and mechanical evidence necessary to obtain affirmative 510(k) clearances for tissue suspension. Reviewing these specific IFUs reveals both the legitimate scope of suspension clearances and their precise anatomical limitations.
Silhouette InstaLift (K163676): The K163676 decision letter is dated June 16, 2017. Silhouette InstaLift is classified under 21 CFR 878.4493 (absorbable poly(glycolide/L-lactide) surgical suture), product code GAM. The 21 CFR 878.4493 identification itself is soft-tissue approximation; the mid-face-suspension sentence is this device's indications-for-use statement, not the entire regulation. The Form FDA 3881 sentence states:
"The Silhouette Instalift device is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position."
The K163676 summary describes an absorbable implant of L-lactide/glycolide bioresorbable resin with bidirectional cones, supplied sterile for single use, with stainless-steel needles. That is a different material family from PDO. Mid-face suspension and 'not intended for lifting and supporting tissues' are therefore separate 510(k) identities, and Silhouette InstaLift is not a PDO-thread identity. This page does not time how long a lift lasts.
MINT Product Family (K192423): The K192423 decision letter is dated September 9, 2020. FDA cleared the MINT Product Family for Hans Biomed Corporation under 21 CFR 878.4840, product code NEW. The 510(k) summary's indication-for-use statement is:
"MINT is indicated for use in mid-face suspension surgery to temporarily fixate the cheek subcutaneous fat layer and SMAS layer in an elevated position for the treatment of moderate to severe nasolabial folds."
K192423 identifies Silhouette InstaLift K163676 as the primary predicate and the original MINT device K130191 as the reference device. The summary describes bi-directional barbs along the long axis of a PDO monofilament. The substantial-equivalence determination authorized marketing of MINT for the stated MINT IFU. It is not a patient-facing finding that the two packets are the same product or material, and it is not permission to substitute the Silhouette IFU for a different PDO packet. Manufacturer pages that collapse K130191, K192423, and K220549 into one 'triple-cleared lift' slogan are marketing; the three public IFU generations still have to be matched to the packet. This page quotes the two later summaries in the source list (K192423 and K220549) and treats K130191 as the reference-device number named in K192423, not as a separately extracted PDF.
MINT Product Family Expansion (K220549): On March 7, 2023, FDA cleared a further expansion (K220549) covering MINT, MINT Lift, and MINT-I Sutures under 21 CFR 878.4840, with primary product code NEW and subsequent product code GAM. Its cleared Indications for Use statement reads:
"The MINT Product Family is comprised of PDO and is indicated for use in soft tissue approximation where use of a barbed absorbable suture is appropriate. These sutures are also indicated for use in face suspension surgery to temporarily fixate the cheek subdermis in an elevated position."
K192423 and K220549 establish that some PDO devices have authentic suspension IFUs (Identity 2). They are not the same sentence. K192423 is mid-face suspension to temporarily fixate the cheek subcutaneous fat layer and SMAS layer for moderate to severe nasolabial folds. K220549 adds face suspension to temporarily fixate the cheek subdermis, while remaining PDO under 21 CFR 878.4840, product code NEW, with subsequent product code GAM on the FDA 510(k) database listing. Subsequent product code GAM does not convert that PDO packet into Silhouette InstaLift.
Those IFU sentences name cheek tissues. They do not name the brow, nasal bridge, neck, or body. This research did not census every absorbable-thread 510(k), so it does not claim that no 510(k) anywhere includes those sites. It does claim that the named public IFUs quoted here do not. Manufacturer pages that list extra example sites (temporal, jowls, neck, eyebrows, nose) are not a substitute for the IFU. If a brochure uses those extra sites, that is an intended-use field under 21 CFR 801.4, not proof that the 510(k) already covers them.
When a price menu lists a brow, cat-eye, or neck thread procedure next to a packet whose IFU is cheek subdermis fixation, copy the IFU first. The extra-site claim is Identity 3 relative to that sentence, even if the same family has a real mid-face-suspension 510(k).
When Marketing Claims Become the Regulatory Intended Use
What occurs from a regulatory and legal standpoint when a medical device cleared strictly for soft-tissue approximation is marketed to clinicians and patients as a cosmetic lifting and tightening treatment? This dynamic represents Identity 3.
The governing legal standard is set forth in 21 CFR 801.4 (Meaning of Intended Uses). The regulation establishes that intended use refers to the objective intent of the persons legally responsible for the labeling of an article. That objective intent is shown by:
Labeling and advertising claims: Printed product cartons, package inserts, official company websites, promotional brochures, and conference exhibits.
Commercial statements: Oral or written statements made by sales representatives, clinical trainers, or authorized distributors.
Distribution circumstances: 21 CFR 801.4 states that intent may also be shown by the design or composition of the article, or by the circumstances surrounding its distribution. This page does not treat a named training course as a surveyed example.
21 CFR 801.4 also states that a firm would not be regarded as intending an unapproved new use based solely on that firm's knowledge that health-care providers were prescribing or using the device for such use. Practitioner off-label use of a suture-cleared thread is therefore a different identity from manufacturer or seller promotion beyond the 510(k). If a packer, distributor, or seller intends different uses than the person from whom the article was received, that seller is required to supply adequate labeling for the new intended uses.
21 CFR 807.81(a)(3)(ii) requires a new 510(k) when a device already in commercial distribution undergoes a major change or modification in intended use. The Les Encres letter applies that rule to promotion of K190264 sutures for tightening and adding volume. It is not a finding that every clinic advertisement is a completed 807.81 case.
FDA warning letter to Les Encres LLC, July 30, 2025: The letter (MARCS-CMS 709263) is signed by Matthew G. Hillebrenner, Deputy Director, Office of Product Evaluation and Quality, Center for Devices and Radiological Health. It is an enforcement letter about Les Encres LLC promotion and quality-system issues, not a finding about every thread brand or every clinic, and not a court judgment.
The underlying clearance: FDA states that Les Encres threads were cleared under K190264 with the following indications: "barbed suture comprised of dyed polydioxanone (PDO) is indicated for use in soft tissue approximation where use of absorbable suture is appropriate." The 510(k) trade name is VIOLA, decision letter August 15, 2019, 21 CFR 878.4840, product code NEW. The warning letter calls the marketed devices Les Encres threads. Those name fields belong on the worksheet as known versus unknown, not as proof they are different devices.
The promotional finding: FDA reviewed information during the March 14 to April 1, 2025 inspection and on the firm's website (one example reviewed July 23, 2025). The letter states that the firm's promotion provides evidence that the devices are intended for specific cosmetic uses, which would constitute a major change or modification to intended use lacking clearance or approval. Website screenshot quotes in the letter did not extract as text for this page; the letter's own words are the claim. FDA characterized those intended uses as tightening and adding volume. This page does not invent additional slogans.
The regulatory citations: FDA determined that the devices, as described and marketed, are adulterated under section 501(f)(1)(B) of the FD&C Act because the firm lacks PMA or IDE for those marketed uses, and misbranded under section 502(o) because the firm introduced the devices into commercial distribution with major changes or modifications to intended use without a new 510(k). The letter cites 21 CFR 807.81(a)(3)(ii).
Material risks named in the letter: "The above intended uses of tightening and adding volume raise safety and effectiveness concerns that are different from those normally associated with the cleared use of the devices. Use of the devices for cosmetic purposes presents additional risks such as migration, extrusion, asymmetry, visible scarring, and poor cosmetic outcomes that generally require clinical data to demonstrate safety in superficial dermal/subdermal use and to confirm the durability and predictability of cosmetic results before such statements can be made." The letter states that the barbed sutures have not been cleared for those indications. Absence of the later 'not intended for lifting and supporting tissues' clause on K190264 is not a lift clearance.
The Les Encres warning letter establishes a definitive regulatory precedent: the mere absence of an explicit 'not intended for lifting' clause (which appeared in K210871 but not in K190264) does not grant permission to market a suture for cosmetic lifting. A clearance for soft-tissue approximation covers wound closure; expanding that clearance into cosmetic lifting, tightening, or volumizing requires a new 510(k) supported by clinical safety and performance data.
Worksheet: Classifying One Named Packet in the Clinic
To operationalize this regulatory framework during a clinical consultation, patients and consulting practitioners can map any candidate thread product into a standardized worksheet. By recording the trade name, 510(k) number, regulation number, product code, and exact Indications for Use sentence, the device's true regulatory identity becomes immediately apparent.
| Trade Name on Packet | 510(k) Number | Regulation & Product Code | Cleared Indications for Use (IFU) Sentence | Missing / Unknown Fields | Regulatory Identity Classification |
|---|---|---|---|---|---|
| Fictional Packet Alpha (Barbed Polydioxanone Suture) | K210871 Model Phrasing | 21 CFR 878.4840 Product Code: NEW | "Indicated for use in soft tissue approximation where use of absorbable sutures is appropriate; anatomical location on the skin for dermatological applications only; not for interior body cavities; not intended for lifting and supporting tissues." | None. Fully documented public 510(k) summary on Form FDA 3881. | Identity 1: 510(k)-cleared absorbable suture with explicit no-lift restriction. |
| Fictional Packet Beta (Resorbable Cone Suture) | K163676 Model Phrasing | 21 CFR 878.4493 Product Code: GAM | "Indicated for use in mid-face suspension surgery to temporarily fixate the cheek subdermis in an elevated position." | None. Fully documented public 510(k) summary. Material is L-lactide/glycolide resin, not PDO. | Identity 2: 510(k)-cleared mid-face suspension device (cheek subdermis fixation). |
| Fictional Packet Gamma (Molded Barbed PDO Thread) | K220549 Model Phrasing | 21 CFR 878.4840 Product Code: NEW (subsequent GAM on the FDA 510(k) database listing) | "Indicated for soft tissue approximation where a barbed absorbable suture is appropriate; also indicated for face suspension surgery to temporarily fixate the cheek subdermis in an elevated position." | None. Fully documented public 510(k) summary. Material is PDO. | Identity 2: 510(k)-cleared face suspension device (cheek subdermis fixation). |
| Fictional Packet Delta (Dyed Barbed PDO Thread) | K190264 Model Phrasing | 21 CFR 878.4840 Product Code: NEW | "Indicated for use in soft tissue approximation where use of absorbable suture is appropriate." (Hypothetical manufacturer or clinic copy promotes tightening and adding volume; not a real case.) | 510(k) number is known; promoted tightening and adding-volume uses are not in that IFU, and no new 510(k) for those uses is identified. | Identity 3: Suture clearance accompanied by commercial claims beyond cleared IFU. |
| Fictional Packet Epsilon (Imported Aesthetic Mono Suture) | Unknown / None provided | Unknown / Unlisted | Unverified. No public 510(k) summary, Premarket Approval, or Form FDA 3881 identified in CDRH database. | 510(k) premarket notification number, manufacturer identity, cleared IFU statement, FDA establishment registration. | Identity 4: Unidentified or unverified medical device. |
Interpreting the worksheet results provides immediate clinical clarity:
Evaluating Identity 1: A packet classified as Identity 1 has a public 510(k) whose indications-for-use sentence is soft-tissue approximation and an express statement that the suture is not intended for lifting and supporting tissues. Using that packet to lift facial tissue is not the cleared intended use in that 510(k). This page does not tell the reader whether to proceed.
Evaluating Identity 2: A packet classified as Identity 2 has a public 510(k) whose indications-for-use sentence includes mid-face or face suspension to temporarily fixate named cheek tissues. That sentence is still limited to what it actually says, including the cheek subdermis. Extra-site claims (brow, neck, nose) are not proved by that cheek-subdermis sentence. Manufacturer example-site lists are not the IFU.
Evaluating Identity 3: A packet classified as Identity 3 has a cleared IFU for one use, while manufacturer or clinic advertising states another. The Les Encres letter is the public manufacturer example for K190264: promotion for tightening and adding volume was treated as a major intended-use change lacking clearance, with named extra risks of migration, extrusion, asymmetry, visible scarring, and poor cosmetic outcomes that generally need clinical data. That letter is not a census of clinic ads and not a finding about every PDO brand.
Evaluating Identity 4: A packet classified as Identity 4 has no identified 510(k) number matching that trade name. A CE mark, the words 'surgical suture,' or a competitor's clearance do not fill that field. The honest mark is unknown, not 'FDA-cleared thread lift.'
If a 510(k) Field Is Blank, Do Not Classify From the Slogan
This page is an identity worksheet, not a 510(k) lookup tutorial. For database mechanics, grey-market imports, and why a CE mark is not a U.S. clearance, use Is That Aesthetic Device FDA-Cleared? How to Verify Any Machine (and Why CE Doesn't Count). For lot numbers and what to request in the record, see Requesting Aesthetic Records: Device Settings, Lot Numbers, and Limits. For documenting off-label use, see Off-Label Aesthetic Treatment Consent: Documenting Risk Clearly. Complications and durability remain separate articles. Provider credentials are a different job (How to choose an injector: credentials, supervision, red flags, and what to ask.).
For the packet in the room, the questions that still have to be answered are:
Trade name: What name is printed on the unopened packet, and is it the same name as the 510(k) summary (for example, VIOLA versus a marketed house name)?
510(k) number: What number is printed on that packet or IFU? If none is produced, the field stays unknown.
IFU sentence: Does the matching public summary mention lifting, mid-face or face suspension, or 'not intended for lifting and supporting tissues'?
Regulation and material: Is the regulation 21 CFR 878.4840 (PDO, product code NEW) or 21 CFR 878.4493 (glycolide/L-lactide, product code GAM)?
Claims versus IFU: If the clinic or manufacturer says lift, tighten, or add volume, is that sentence in the 510(k) IFU, or is it a separate intended-use field under 21 CFR 801.4?
Unknown fields: If the packet has no 510(k) number, which fields are unknown, and what is not proved by a CE mark, 'surgical suture,' or a competitor's clearance? If those answers are blank, the next step is delaying the procedure until the IFU is produced. This page does not choose a treatment.
Sources
The analysis and regulatory determinations in this guide are grounded exclusively in primary statutes, federal regulations, official FDA guidance documents, 510(k) premarket notification summaries, and published enforcement actions:
FDA 510(k) Summary K210871: PDO Max Suture with Dual Needle — U.S. Food and Drug Administration (December 17, 2021). Classifies absorbable polydioxanone surgical suture under 21 CFR 878.4840, product code NEW, with explicit indications restricting use to dermatological soft-tissue approximation and stating that the suture is not intended for lifting and supporting tissues.
FDA 510(k) Summary K190245: PDS Barbed Suture / PDO MAXX Threads — U.S. Food and Drug Administration (June 4, 2019). Classifies barbed polydioxanone suture under 21 CFR 878.4840, product code NEW, with identical four-part restrictions disclaiming lifting and tissue support.
FDA 510(k) Summary K242571: Secret Line up and i-Thread — U.S. Food and Drug Administration (September 27, 2024). Establishes ongoing regulatory requirement under 21 CFR 878.4840, product code NEW, restricting dermatological soft-tissue approximation sutures from lifting and supporting tissues.
FDA 510(k) Summary K163676: Silhouette InstaLift Absorbable Suture — U.S. Food and Drug Administration (June 16, 2017). Classifies poly(glycolide/L-lactide) suture with bidirectional cones under 21 CFR 878.4493, product code GAM, indicated for mid-face suspension surgery to temporarily fixate the cheek subdermis in an elevated position.
FDA 510(k) Summary K192423: MINT Product Family — U.S. Food and Drug Administration (September 9, 2020). Substantial equivalence determination under 21 CFR 878.4840, product code NEW, authorizing mid-face suspension surgery to temporarily fixate the cheek subcutaneous fat layer and SMAS layer for moderate to severe nasolabial folds.
FDA 510(k) Summary K220549: MINT Lift and MINT-I Sutures — U.S. Food and Drug Administration (March 7, 2023). Classifies barbed PDO sutures under 21 CFR 878.4840, product codes NEW and GAM, indicated for soft tissue approximation and face suspension surgery to temporarily fixate the cheek subdermis in an elevated position.
FDA 510(k) Decision Letter K190264: VIOLA Barbed Suture — U.S. Food and Drug Administration (August 15, 2019). Substantial equivalence clearance under 21 CFR 878.4840, product code NEW, restricted solely to soft tissue approximation where absorbable suture is appropriate.
FDA Warning Letter to Les Encres LLC (CMS # 709263) — U.S. Food and Drug Administration (July 30, 2025). Warning letter establishing that commercial promotion of soft-tissue approximation sutures for tightening and adding volume constitutes an unapproved major modification of intended use under 21 CFR 807.81(a)(3)(ii), citing material risks of thread migration, extrusion, asymmetry, and scarring.
21 CFR 801.4 — Meaning of Intended Uses — Code of Federal Regulations, Title 21, Food and Drugs. Defines intended use by objective marketing intent, establishes distributor labeling obligations, and provides the health-care provider prescribing safe harbor.
21 CFR 807.81 — When a Premarket Notification Submission Is Required — Code of Federal Regulations, Title 21. Mandates submission of a new 510(k) premarket notification for major modifications in device intended use that could significantly affect safety or effectiveness.
21 CFR 807.92 — Content and Format of a 510(k) Summary — Code of Federal Regulations, Title 21. Requires detailed articulation of intended use, anatomical target sites, and predicate comparison within public 510(k) summaries.
21 CFR 807.97 — Misbranding by Reference to Premarket Notification — Code of Federal Regulations, Title 21. Establishes that premarket notification clearance does not denote official FDA approval and that representations creating an impression of official approval constitute illegal misbranding.
21 CFR 878.4840 — Absorbable Polydioxanone Surgical Suture — Code of Federal Regulations, Title 21. Classifies absorbable polydioxanone sutures as Class II prescription devices indicated for soft tissue approximation.
21 CFR 878.4493 — Absorbable Poly(glycolide/L-lactide) Surgical Suture — Code of Federal Regulations, Title 21. Classifies absorbable glycolide/lactide copolymer sutures as Class II devices subject to special controls.
FDA Premarket Notification 510(k) Regulatory Overview — U.S. Food and Drug Administration. Clarifies substantial equivalence standards, clearance mechanics, and premarket requirements for commercial distribution in the United States.
