Solta Medical holds 32 FDA 510(k) clearances under applicants Reliant Laser, Reliant Technologies, Thermage Inc., and Solta Medical, spanning 1992-05-21 (the Reliant-era Unimax CO2) through 2024-08-21 (Fraxel FTX). The company was formed when Thermage (ThermaCool RF) acquired Reliant Technologies (Fraxel) in a merger completed on December 23, 2008 and renamed the combined company Solta Medical, Inc. in January 2009; Valeant acquired Solta on 2014-01-23 for 2.92 dollars per share and Valeant later became Bausch Health. Solta is today a wholly-owned aesthetic business of Bausch Health Companies (NYSE: BHC), headquartered in Bothell, WA; the December 2025 Shibo deal was Solta acquiring its China distributor, not a sale of Solta. The current portfolio is Thermage FLX (monopolar RF skin tightening), Fraxel / Fraxel FTX (fractional laser), Clear+Brilliant Touch (1927 nm skin rejuvenation), VASERlipo (ultrasound-assisted liposuction), and Isolaz (light-based acne). In openFDA MAUDE, brand matching across the Solta portfolio yields 394 reports and 374 Injury reports; the signal is dominated by Fraxel (189 reports, 176 Injury) and VASER (159 reports, 155 Injury, 1 Death), while Thermage, the most-recognized brand, has only 6 reports.
How many FDA 510(k) clearances does Solta Medical hold, and what is the Reliant plus Thermage lineage?
Regulatory clearance analysis
A search of the FDA’s Premarket Notification 510(k) database for Solta Medical and its predecessor entities—Reliant Technologies, Reliant Laser Corporation, Thermage Inc., and Aesthera—yields 32 total clearances.
These clearances span more than three decades of medical device development, reflecting the evolution of skin tightening and fractional laser resurfacing:
- Earliest Clearance: May 21, 1992, for the Unimax Model 2000 Color-Corrected Microspot CO2 Laser (K920821) under applicant Reliant Laser Corporation. This represents the early carbon dioxide laser technology that preceded fractional resurfacing.
- Latest Clearance: August 21, 2024, for the Fraxel FTX Laser System (K242142) under applicant Solta Medical. This device is the latest generation of the Fraxel family, which launched in the United States in April 2025.
- Key Mid-Era Milestones: Cleared systems include the Thermage ThermaCool TC System (K013824) on November 19, 2001 (representing the first FDA-cleared monopolar radiofrequency device for aesthetic skin tightening), the Reliant SR1500 Fractional Laser (K051790) on August 19, 2005 (the commercial foundation of the Fraxel re:store line), and the Clear+Brilliant Touch Laser System (K223647) on December 29, 2022.
The product codes for these 32 clearances concentrate in:
- GEX (Powered Laser Surgical Instrument): The regulatory pathway for the Fraxel erbium/thulium fiber lasers and the Clear+Brilliant fractional systems.
- ONG (Laser, Surgical, Gynecological/Urological): Used for surgical-adjacent light-delivery systems.
- QPB (Electrosurgical Charged-Device for Aesthetic Skin Treatment): The pathway under which the Thermage radiofrequency consoles are cleared, ensuring electrical and thermal output safety.
Corporate heritage: The combination of Thermage and Reliant
Solta Medical's current profile is the product of multiple corporate combinations:
- Thermage Inc.: Founded in 1996, Thermage pioneered the use of monopolar radiofrequency (RF) energy to heat deep dermal tissue while cooling the epidermis, causing immediate collagen contraction and subsequent neocollagenesis.
- Reliant Technologies: Reliant pioneered "fractional photothermolysis" in the early 2000s. Rather than ablating the entire skin surface, fractional lasers create thousands of microscopic treatment zones (MTZs) surrounded by spared tissue, leading to rapid healing and low downtime.
- The 2008 Merger: In July 2008, Thermage agreed to acquire Reliant Technologies for approximately 95 million dollars in cash and stock. The transaction closed on December 23, 2008, and the combined company was renamed Solta Medical, Inc. (from "sun," sol, and "volt," ta) effective January 12, 2009.
- Subsequent Acquisitions: Solta expanded its footprint by acquiring Aesthera Corporation in 2010 (developer of the Isolaz vacuum-assisted IPL acne system) and Sound Surgical Technologies in 2013 (developer of the VASERlipo ultrasound-assisted liposuction system).
This series of mergers created a single manufacturer portfolio that owned three of the most recognizable energy-device brand names in aesthetic medicine: Thermage, Fraxel, and VASER.
What is Solta's current aesthetic portfolio by technology (RF, fractional laser, ultrasound lipo)?
Solta Medical’s product lines utilize distinct physical modalities to address skin laxity, texture, localized fat, and acne.
| Brand Family | Core Technology | Primary Wavelength / Energy Type | Key FDA Clearance (510k) | Primary Clinical Indications |
|---|---|---|---|---|
| Thermage FLX | Monopolar Radiofrequency (RF) | 6.78 MHz RF / Cryogen-Cooled | K172186 (Console) / K211910 (Tips) | Non-invasive skin tightening, facial wrinkle reduction, eyelid laxity |
| Fraxel DUAL (1550/1927) | Fractional Erbium & Thulium Fiber Laser | 1550 nm & 1927 nm | K081498 (DUAL) / K141443 (re:store) | Skin resurfacing, acne scars, actinic keratosis, melasma, pigment |
| Fraxel FTX | Fractional Erbium & Thulium Fiber Laser | 1550 nm & 1927 nm | K242142 (Fraxel FTX) | Skin resurfacing, photodamage, scars (US launch April 2025) |
| Clear+Brilliant Touch | Gentle Fractional Laser | 1440 nm & 1927 nm (Intelligent Optical Tracking) | K111162 (Original) / K223647 (Touch) | Skin texture improvement, pore reduction, early photodamage |
| VASERlipo (VASER Amp) | Ultrasound-Assisted Liposuction | 36 kHz Continuous/Pulsed Ultrasound | K172605 (VASER Amp / VASER Lipo) | Ultrasound-assisted lipoplasty, body contouring, fat emulsification |
| Liposonix | High-Intensity Focused Ultrasound (HIFU) | 2 MHz Focused Ultrasound | K111181 (Liposonix Model Two) | Non-invasive waist circumference reduction, localized fat ablation |
| Isolaz / Isolaz 2 | Broadband Light & Pneumatic Vacuum | 400–1200 nm IPL + Vacuum | K052674 (Original) / K100984 (Isolaz 2) | Treatment of inflammatory, pustular, and comedonal acne vulgaris |
Monopolar Radiofrequency: Thermage FLX
The Thermage FLX represents the fourth generation of Solta's monopolar radiofrequency technology. Operating at 6.78 MHz, the system delivers capacitive radiofrequency energy into the deep dermis and subcutaneous tissues. The resistance of the tissue to the current generates heat, reaching an internal target temperature of 55 to 65 degrees Celsius. This thermal energy denatures the triple-helix structure of collagen fibers, causing immediate contraction and initiating a wound-healing response that deposits new collagen over 2 to 6 months.
- Epidermal Protection: To prevent epidermal burns, the Thermage handpiece utilizes a liquid cryogen spray (cryogen canisters) that cools the skin surface immediately before, during, and after each RF pulse.
- AccuREP™ Technology: The FLX system features real-time tuning, measuring the electrical impedance of the tissue at the local treatment site before every pulse and automatically adjusting the energy output to ensure consistent heating.
- Clinical Efficacy: A multicenter randomized non-inferiority trial using Thermage CPT as the active control (PMC12948897) reported effective rates near 90 percent at 90 and 180 days, with high patient satisfaction and no serious device-related adverse events.
Fractional Lasers: Fraxel and Clear+Brilliant
The Fraxel brand is synonymous with fractional resurfacing. Its current flagship system, the Fraxel DUAL 1550/1927, features two distinct laser wavelengths in a single console:
- 1550 nm Erbium Fiber Laser: A deep-penetrating, non-ablative laser that targets water. It creates microscopic column-like thermal injuries down to the mid-to-deep dermis, primarily used for structural remodeling (acne scars, deep wrinkles, surgical scars).
- 1927 nm Thulium Fiber Laser: A shallower, non-ablative laser with high water absorption. It targets the epidermis and superficial dermis, primarily used to treat pigmentation, solar lentigines, melasma, and actinic keratosis.
The Fraxel FTX (FDA cleared under K242142 on August 21, 2024) is the latest evolution, incorporating updated user interfaces, optimized spot density algorithms, and improved optical tracking. For patients deciding on laser resurfacing, see how Fraxel compares contextually in our resurfacing comparison guide.
The Clear+Brilliant family is positioned as a "preventative" or maintenance fractional laser. Utilizing a lower energy profile than Fraxel, it delivers gentle micro-pulses to improve skin barrier permeability and texture with virtually zero downtime. The Clear+Brilliant Touch (cleared under K223647 on December 29, 2022) combines both the 1440 nm (original) and 1927 nm (Perméa) wavelengths on a single touchscreen interface, allowing clinicians to switch between structural and pigment treatments during a single session. For treatment planning, see our Moxi vs Clear+Brilliant guide.
Ultrasound Liposuction: VASERlipo
The VASERlipo (Vibration Amplification of Sound Energy at Resonance) system is an invasive surgical platform. It utilizes a solid titanium probe that vibrates at 36 kHz to emit ultrasound energy. This energy causes acoustic cavitation within the tumescent fluid injected into the fat layer. The microscopic bubbles expand and collapse, emulsifying adipose tissue into a liquid state while leaving blood vessels, nerves, and connective tissue sheath intact. This reduces surgical trauma, minimizes bleeding, and results in smoother contours compared to traditional mechanical liposuction.
What does the MAUDE safety profile show, and why do Fraxel and VASER dominate instead of Thermage?
The Solta Portfolio Safety Split
A search of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database for Solta Medical portfolio brands (including Fraxel, Clear+Brilliant, Thermage, ThermaCool, Isolaz, VASER, Liposonix, and PowerX) yields 394 total reports.
A breakdown of these 394 reports reveals a stark concentration of adverse events in specific product lines:
- Total Injury Reports: 374 reports (~95%).
- Total Malfunction Reports: 6 reports (~1.5%).
- Total Death Reports: 1 report (~0.25%).
- Total Other/Unclassified Reports: 13 reports (~3.25%).
When split by device family, the safety signals are distributed as follows:
| Device Family | Total Reports | Injury Reports | Malfunctions | Deaths | Primary Adverse Event Descriptions |
|---|---|---|---|---|---|
| Fraxel (All Models) | 189 | 176 | 4 | 0 | Severe epidermal burns, blistering, scarring, hyperpigmentation, hypopigmentation |
| VASERlipo (VASER Amp) | 159 | 155 | 1 | 1 | Deep thermal burns, contour irregularities, fluid accumulation (seroma), systemic surgical complications |
| Liposonix | 34 | 33 | 0 | 0 | Severe pain during treatment, localized blistering, persistent subcutaneous nodules |
| Thermage / ThermaCool | 6 | 4 | 1 | 0 | Localized surface burns, temporal nerve swelling (transient facial asymmetry), skin depression |
| Isolaz / Isolaz 2 | 5 | 5 | 0 | 0 | Localized bruising, petechiae, mild surface blistering |
| Clear+Brilliant (All) | 1 | 1 | 0 | 0 | Prolonged facial redness and dry texture resolving post-procedure |
Total reports include additional entries classified as "Other" or without an event classification; the Malfunction and Death columns list only those specific categories, so rows need not sum to the family total.
Why do Fraxel and VASER dominate the safety record?
Thermage is the most widely recognized and installed brand in Solta's portfolio, yet it has only 6 total MAUDE reports (with only 4 classified as injuries) over its multi-decade history. In contrast, Fraxel and VASER account for 348 of the 394 total reports (88.3%).
This difference is explained by the physics of energy delivery and the surgical nature of the procedures:
Monopolar RF vs. Optical Laser Energy (Thermage vs. Fraxel):
- Thermage is a non-invasive treatment that does not disrupt the epidermis. Its safety is supported by the built-in AccuREP impedance feedback, which prevents hotspots, and the liquid cryogen cooling.
- Fraxel delivers light energy to target water. If the operator selects too high an energy level (mJ) or too high a density (dots/cm²) on a patient with darker skin (Fitzpatrick IV–VI), the excessive absorption of energy by melanin leads to epidermal burns, blistering, and post-inflammatory hyperpigmentation (PIH). The fractional columns, while designed to heal quickly, still break the skin barrier, creating a risk of secondary infection if post-procedure hygiene is not maintained.
Surgical Intervention vs. Non-Invasive Procedures (VASER vs. Thermage):
- VASERlipo is an invasive surgical procedure. It involves inserting a metal probe through incisions under tumescent anesthesia.
- MAUDE reports for VASER describe serious complications, including deep skin burns (caused by the probe touching the dermis without sufficient fluid or movement, leading to friction and thermal transfer), seromas, infection, and contour deformities.
- The single death-classified report in the Solta portfolio match (Report 3011423170-2022-00076, a foreign report from India received June 14, 2022) names the VASERlipo system. The reporting facility stated that a patient died after a liposuction procedure in which the VASER amplifier was used; local media attributed the death to pulmonary edema. The treating physician reported no device malfunction, declined to return the console for evaluation, and confirmed the amplifier was working as intended, and Solta's post-market analysis concluded that mortality from liposuction using VASER is improbable. As with all MAUDE entries, the report alleges device involvement without establishing that the device caused the death.
Who owns Solta Medical today, and did Bausch sell it in 2025?
Valeant, Bausch Health, and the Corporate Structure
Solta Medical is currently a wholly-owned subsidiary of Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals International, Inc.).
The transition to this ownership structure occurred through the following sequence:
- 2013 Acquisition: On December 16, 2013, Valeant Pharmaceuticals announced an agreement to acquire Solta Medical for 2.92 dollars per share in cash, valuing the transaction at approximately 250 million dollars. The acquisition was completed on January 23, 2014.
- Corporate Rebrand: In 2018, Valeant changed its name to Bausch Health Companies Inc. to distance itself from prior debt crises and focus on its eye care (Bausch + Lomb) and aesthetic divisions.
- Proposed Carve-Out: In 2021, Bausch Health announced plans to launch an Initial Public Offering (IPO) of Solta Medical to establish it as a standalone publicly traded company. A registration statement on Form S-1 was filed with the SEC in early 2022. However, due to unfavorable macroeconomic conditions and market volatility, Bausch Health suspended the IPO process in mid-2022. Solta remains integrated within Bausch Health's corporate reporting structure.
As of the Bausch Health annual report (SEC Form 10-K, file bhc-20251231) for the fiscal year ended December 31, 2025, Solta Medical is operated as a reporting segment of Bausch Health, with its financials consolidated into BHC’s overall results.
Clarifying the December 2025 China Transaction
A common error in trade publications and clinic blogs is the assertion that Bausch Health sold Solta Medical in late 2025. This conflates the target of a transaction with the acquirer.
- The Transaction: On December 1, 2025, Bausch Health announced that Solta Medical had completed the acquisition of the distribution business of the Shibo Group (Wuhan Shibo Zhenmei Technology Co., Ltd. and its affiliates) in China.
- The Context: The Shibo Group had served as Solta’s third-party distributor in China for many years, managing the import, sale, and support of the Thermage FLX and Thermage CPT platforms.
- The Outcome: Solta was the acquirer. By purchasing Shibo’s aesthetic distribution network, Solta Medical took direct control of its operations, sales force, and regulatory compliance in mainland China. This allows Solta to sell Thermage FLX directly to Chinese medical facilities and clinics, capturing distributor margins and direct-to-market revenue. Solta Medical remains wholly owned by Bausch Health.
Are the Fraxel MAUDE injury reports a safety concern for fractional laser resurfacing?
Analysis of reported injuries
The 176 injury reports in openFDA MAUDE associated with the Fraxel laser family do not indicate a design defect or mechanical failure. Instead, they illustrate the risks of fractional laser resurfacing when treatments are not customized to the patient's skin type or post-procedure guidelines are not followed:
Laser Burns and Blistering: These are typically caused by:
- High Pulse Energy: Delivering excessive energy (mJ) that exceeds the thermal relaxation time of the local tissue.
- Incorrect Treatment Density: Setting the treatment coverage percentage (e.g., 20% to 30%) too high for a single pass, leading to bulk heating rather than isolated micro-zones.
- Inadequate Contact Cooling: The Fraxel handpiece relies on a continuous stream of cold air (using an external Zimmer chiller). If the chiller is set too low or the air flow is blocked, epidermal temperature rises, causing superficial burns.
Post-Inflammatory Hyperpigmentation (PIH): PIH is a known risk for patients with Fitzpatrick Skin Types IV through VI (olive to dark brown skin).
- Mechanism: Laser energy stimulates epidermal melanocytes, causing an overproduction of melanin during the healing phase.
- Prevention: Clinicians should use the thulium fiber wavelength (1927 nm) with low energy and density settings on darker skin, prep the skin with topical tyrosinase inhibitors (such as hydroquinone), and enforce strict post-procedure sun protection.
Scarring and Infection: Reports of scarring are rare and usually associated with secondary bacterial (e.g., Staphylococcus) or viral (Herpes Simplex virus outbreak) infections that occur when the skin barrier is compromised, or when patients pick at peeling skin.
FDA Recalls and Safety Records
Two Class II FDA recalls have historically affected the Fraxel product lines, both of which were resolved by Solta Medical:
- Recall Z-1010-2011 (Fraxel re:store Dual System): Initiated on December 15, 2010. The recall was issued because a software bug in the console's firmware could cause the optical tracking sensor to miscalculate handpiece velocity, occasionally leading to uneven treatment delivery or high energy density. Solta resolved the issue via a field software patch.
- Recall Z-1463-2014 (Fraxel Dual 1550/1927 Laser System): Initiated on March 20, 2014. The recall was issued due to a manufacturing defect where the internal cooling fan could fail, leading to thermal shutdown of the laser module. Affected units were repaired by Solta field technicians.
Questions to Ask a Solta Device Distributor or Provider
For medical directors, clinic buyers, and clinicians seeking to purchase new or pre-owned Solta devices, or for patients evaluating treatment options, the following questions should be asked to verify safety and compliance:
- "For pre-owned Thermage FLX consoles: Has the console's handpiece connector been upgraded to the latest firmware to support the 4.0 cm² total-tip integration?"
- Why: Early Thermage FLX consoles require software updates to recognize newer treatment tips, which feature larger spot sizes designed to shorten procedure times.
- "For pre-owned Fraxel Dual lasers: Has the internal fiber laser source been replaced or calibrated within the last 1,000 hours of operation?"
- Why: Erbium and thulium fiber lasers degrade over years of use, leading to drop-offs in output energy. A system that has not been calibrated may deliver lower fluence than displayed, compromising results.
- "For patients considering Thermage FLX: What is the expiration date on the single-use treatment tip, and is it a genuine Solta Medical tip?"
- Why: Thermage tips contain an encrypted EEPROM chip that prevents re-use and verifies authenticity. Counterfeit tips lack this chip or bypass it, posing a risk of contact burns due to faulty membrane cooling.
- "For patients considering Fraxel: What Fitzpatrick safety protocols do you use, and do you recommend a pre-treatment skin regimen?"
- Why: The provider should evaluate your skin type and, if you are Fitzpatrick Type IV or higher, explain how they will adjust the laser parameters to prevent post-inflammatory hyperpigmentation.
Sources
- U.S. Food and Drug Administration. "510(k) Premarket Notification Database: Fraxel FTX Laser System (K242142)." FDA, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cf510k/510k.cfm?id=K242142
- U.S. Food and Drug Administration. "510(k) Premarket Notification Database: Clear+Brilliant Touch Laser System (K223647)." FDA, 2022. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cf510k/510k.cfm?id=K223647
- U.S. Securities and Exchange Commission. "Bausch Health Companies Inc. Form 10-K for the Fiscal Year Ended December 31, 2025." SEC, 2026. https://www.sec.gov/Archives/edgar/data/885590/000088559026000023/bhc-20251231.htm
- Bausch Health Companies Inc. "Valeant Pharmaceuticals International, Inc. Completes Acquisition of Solta Medical." Bausch Investor Relations, 2014. https://ir.bauschhealth.com/news-releases/archive/2013/16-12-2013
- Bausch Health Companies Inc. "Solta Medical Acquires the Shibo Group Distribution Business in China." Bausch Investor Relations, 2025. https://ir.bauschhealth.com/news-releases/2025/12-01-2025
- Li, X., et al. "Efficacy and safety of a novel monopolar radiofrequency device for skin tightening versus Thermage CPT: a multicenter, randomized, evaluator-blinded, active-controlled, non-inferiority trial." PubMed Central, 2024. https://pmc.ncbi.nlm.nih.gov/articles/PMC12948897
- U.S. Food and Drug Administration. "Manufacturer and User Facility Device Experience (MAUDE) Database: Solta Medical Brand Search." FDA, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
