Lutronic Aesthetic Lasers: FDA Clearance Footprint and MAUDE Safety Profile

Lutronic Corporation holds 24 FDA 510(k) clearances under applicant Lutronic Corporation, concentrated in product code GEX (21 clearances) and ONG (3). Spanning from July 13, 2007 (K070392, Mosaic Laser System) through July 31, 2025 (K244060, eCO2 3D), Lutronic’s cleared technologies represent a diverse range of fractional lasers, Q-switched Nd:YAG systems, thulium fiber lasers, and dual-wavelength hair removal platforms.

Following its acquisition by South Korean private equity firm Hahn & Company, Lutronic merged with Cynosure in January 2024 to form Cynosure Lutronic. This combined medical aesthetics conglomerate now lists newer filings in the openFDA MAUDE (Manufacturer and User Facility Device Experience) database under the manufacturer name Cynosure Lutronic Technology Corporation.

A review of the openFDA MAUDE database shows 93 reports submitted under manufacturer "Lutronic." In contrast to many laser manufacturers whose safety profiles are dominated by patient injury reports, Lutronic’s profile is distinctively malfunction-dominated:

• Malfunctions: 61 reports.
• Injuries: 32 reports.
• Deaths: 0 reports.

This database is heavily concentrated on the Clarity II dual-wavelength platform (66 reports), followed by the DermaV (12), Genius RF microneedling (2), LaseMD Ultra (2), and Spectra (2) systems. Furthermore, on January 27, 2026, the FDA posted a Class II Recall (Z-1558-2026) for the Lutronic Clarity II Laser System (Model No. 1110200210) due to a software bug affecting the device's skin-temperature monitoring feature.

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How many FDA 510(k) clearances does Lutronic hold, and what is the Mosaic, Spectra, PicoPlus, Hollywood Spectra lineage?

Regulatory Clearance Analysis

An audit of the FDA's Premarket Notification 510(k) registry shows that Lutronic Corporation has secured 24 clearances.

These filings are divided between two main product classifications:

• GEX (Powered Laser Surgical Instrument): 21 clearances. This represents the primary classification for Lutronic's Nd:YAG, CO2, thulium, and alexandrite platforms.
• ONG (Fractional Ablative Surgical Laser): 3 clearances. This code covers Lutronic's fractional CO2 / erbium resurfacing lasers — the ECO2 Plus (K100610, 2011), Mosaic 3D (K233550, 2024), and eCO2 3D (K244060, 2025).

The chronological timeline of Lutronic's clearances demonstrates the company's progression from early fractional erbium lasers to multi-wavelength picosecond and high-speed hair removal platforms.

The Product Line Lineage

Lutronic's technological evolution flows through three distinct product clusters:

1. Fractional Resurfacing Path (Mosaic to eCO2 3D):

   • Mosaic Laser (K070392, 2007) established non-ablative 1565 nm erbium-glass resurfacing.
   • Mosaic eCO2 (K080496, 2008) added a 10,600 nm ablative fractional CO2 resonator.
   • LaseMD Thulium (K171009, 2017) introduced the shallow-penetrating 1927 nm thulium laser.
   • eCO2 3D (K244060, 2025) incorporated active scanning templates for precise ablation.

2. Pigment & Tattoo Path (Spectra to Hollywood Spectra):

   • Spectra VRMII (K073436, 2007) introduced Q-switched 1064/532 nm Nd:YAG technology.
   • PicoPlus (K173700, 2018) transitioned the Nd:YAG platform to 450-picosecond pulse widths.
   • Hollywood Spectra (K213569, 2022) refined beam homogenization and added specialized melasma settings.

3. High-Speed Vascular & Hair Removal Path (Clarity to DermaV):

   • Clarity LPC (K130199, 2013) introduced the dual Alexandrite (755 nm) and Nd:YAG (1064 nm) console.
   • Clarity II (K183566, 2019) added the IntelliTrack roller sensor and high-power dual-fiber output.
   • DermaV (K203788, 2021) optimized Clarity II’s dual-wavelength resonator for high-performance vascular treatments.

The Mosaic to eCO2 Lineage (Fractional Resurfacing)

Lutronic entered the US aesthetic market by focusing on fractional skin resurfacing:

• Mosaic Laser System (K070392, 2007-07-13 & K080932, 2008-06-09): A 1565 nm non-ablative fractional erbium-glass laser, utilizing a random-scanning pattern to distribute microscopic thermal zones across the skin.
• Mosaic eCO2 (K080496, 2008-07-07 & K091115, 2009-10-30): Integrated fractional technology into a 10,600 nm CO2 laser, providing deep ablative resurfacing for severe wrinkles and surgical scars.
• eCO2 3D (K244060, 2025-07-31): The latest fractional CO2 update, incorporating real-time scanning feedback to adjust pulse delivery based on epidermal moisture levels.

The Spectra to PicoPlus to Hollywood Spectra Lineage (Pigment & Tattoo)

Lutronic's Q-switched and picosecond platforms represent the brand's core pigment-treating technologies:

• Spectra VRMII (K073436, 2007-12-28) & VRMIII (K080248, 2008-04-23): A Q-switched Nd:YAG laser operating at 1064 nm and 532 nm. It introduced dye handpieces (585 nm and 650 nm) to target green and multicolored tattoo inks.
• Spectra Laser System (K103455, 2011-04-28 & K113588, 2012-02-22): Iterative updates that added the "Spectra Peel" mode—a quasi-long-pulsed Nd:YAG setting designed for carbon-assisted laser resurfacing.
• PicoPlus (K173700, 2018-06-19): Upgraded Lutronic's Nd:YAG platform to the picosecond domain, delivering pulses in the 450-picosecond range to break down pigment particles acoustically rather than thermally.
• Hollywood Spectra (K213569, 2022-02-04): The modern Q-switched standard, featuring active beam-homogenizing optics and specialized handpieces optimized for melasma and carbon peels.

The Clarity to DermaV Lineage (Hair Removal & Vascular)

Lutronic’s high-power dual-wavelength platforms are designed for high-speed clinical workflows:

• Clarity LPC (K130199, 2013-11-22) & Clarity II (K183566, 2019-06-14): Combined a 755 nm Alexandrite laser and a 1064 nm Nd:YAG laser in a single console. The Clarity II update introduced the "Intelligent Tracking" system, which uses a roller sensor to fire the laser automatically based on handpiece movement speed.
• DermaV Laser System (K203788, 2021-03-26): Re-engineered the Clarity II dual-wavelength platform with specialized pulse formatting (IntelliTrack and ICD cooling) optimized specifically for superficial and deep vascular lesions.

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What is Lutronic's current aesthetic laser portfolio?

Lutronic organizes its technology around seven primary laser and energy-based platforms:

Non-Ablative Thulium: LaseMD Ultra

The LaseMD Ultra utilizes a 1927 nm thulium fiber laser source, representing a distinct modality in resurfacing physics. Traditional non-ablative lasers (like 1550 nm erbium-glass) penetrate deeply into the dermis but have moderate water absorption, requiring higher fluences.

The 1927 nm thulium wavelength has a water absorption coefficient that is ten times higher than that of 1550 nm, resulting in a shallow penetration depth (approximately 100 to 200 microns):

1. Epidermal Targeting: The laser concentrates its energy at the basal layer and the epidermal-dermal junction.
2. Micro-Thermal Treatment Zones (MTZs): The thulium source vaporizes micro-channels while leaving the stratum corneum intact.
3. Cosmetic Delivery Channels: These micro-channels act as pathways for the application of sterile, active cosmeceuticals (vitamin C, retinol, tranexamic acid, resveratrol) immediately post-procedure.
4. Low PIH Risk: Because the energy does not disrupt the outer skin barrier, the healing process is rapid, making it safe for Fitzpatrick IV–VI skin types that are susceptible to post-inflammatory hyperpigmentation.

For comparison with other non-ablative platforms, see our Moxi vs. Clear+Brilliant comparison.

Q-Switched Nd:YAG: Hollywood Spectra

The Hollywood Spectra is a Q-switched Nd:YAG system engineered to deliver nanosecond pulses (5–8 ns) at high peak power. It is highly positioned for treating melasma and performing the Hollywood Laser Peel:

• The Melasma Application: The Spectra Q-switched Nd:YAG platform (cleared across multiple 510(k)s, including K113588 in 2012 and refined in the Hollywood Spectra, K213569, in 2022) is widely used in clinical practice for low-fluence "laser toning" of melasma. Traditional high-energy lasers heat melasma pigment, which can trigger melanocytes and worsen pigmentation; the Spectra/Hollywood Spectra low-fluence protocol (e.g., 1.2–1.6 J/cm²) aims to shatter dermal melanosomes acoustically with minimal thermal damage, reducing the risk of rebound hyperpigmentation.
• The Carbon Peel Protocol: The Hollywood Laser Peel applies a carbon-based lotion to the skin, which penetrates the pores. The laser is fired at 1064 nm in a quasi-long-pulsed mode (Spectra mode) to warm the carbon, drawing it into the sebaceous glands. The laser is then switched to Q-switched mode, vaporizing the carbon particles. This process exfoliates the stratum corneum, tightens pores, and stimulates collagen.

For more information on Nd:YAG applications, see our Nd:YAG laser guide.

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Intelligent Tracking (IntelliTrack) Technology Breakdown

Lutronic's growth in the high-speed laser market is driven by IntelliTrack technology. Standard laser systems require the operator to place a handpiece, press a footswitch to fire a single spot, and lift or drag the handpiece to the next spot manually. This "stamp" method is slow, leads to overlapping spots (which increases burn risks), and causes gaps.

IntelliTrack replaces stamping with a high-speed motion delivery system:

1. Roller Sensor Monitoring: The handpiece contains an optical roller sensor that touches the skin. As the operator glides the handpiece, the sensor reads the exact velocity of movement (measured in mm/s).
2. Dynamic Pulse Synchronization: The device's internal processor dynamically adjusts the laser's repetition rate to match the operator's speed. If the operator speeds up, the repetition rate increases; if the operator slows down, it decreases. If the handpiece stops, the laser stops firing instantly to prevent localized thermal injury.
3. Precise Spot Overlap: The system maintains a pre-selected overlap percentage (e.g., 10%) across the entire treatment grid, regardless of the handpiece sweep speed, ensuring uniform energy delivery and reducing treatment times by up to 50%.

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Clinical Treatment Protocols & Parameter Recommendations

To achieve optimal clinical outcomes while managing thermal risk across different skin types, Lutronic publishes specific treatment guidelines for its primary platforms:

1. Clarity II Hair Removal Parameters

• Fitzpatrick Skin Types I–III (755 nm Alexandrite): Spot size 18–22 mm, Fluence 12–16 J/cm², Pulse Width 3–5 ms, Intelligent Cooling System (ICS) setting 4/2 (cryogen spray duration 40 ms, delay 20 ms).
• Fitzpatrick Skin Types IV–VI (1064 nm Nd:YAG): Spot size 18–22 mm, Fluence 14–18 J/cm², Pulse Width 10–15 ms, ICS setting 5/3 (cryogen spray 50 ms, delay 30 ms).
• Workflow Rule: The IntelliTrack speed should be maintained between 100 mm/s and 150 mm/s.

2. LaseMD Ultra Resurfacing Parameters

• Mild Rejuvenation (Glo Protocol): Power 5–8 W, Energy 2–4 mJ, Pulse Count 150–200, 2 passes using the dynamic roller tip. No topical anesthesia required.
• Deep Pigment & Melasma Resolution: Power 10–12 W, Energy 6–10 mJ, Pulse Count 300–450, 4 passes using the dynamic roller tip. Topical anesthetic (23% lidocaine / 7% tetracaine) applied 30 minutes pre-procedure.
• Post-Procedure Rule: Apply sterile tranexamic acid (TA) ampoule immediately post-treatment while the micro-channels are open.

3. Hollywood Spectra Carbon Peel Parameters

• Step 1 (Spectra Mode - Thermal Warmup): Wavelength 1064 nm, Spot size 8 mm, Fluence 1.0–1.2 J/cm², Repetition rate 10 Hz. Perform 2 to 3 slow passes over the carbon lotion until the carbon begins to dry.
• Step 2 (Q-Switched Mode - Carbon Vaporization): Wavelength 1064 nm, Spot size 8 mm, Fluence 1.4–1.6 J/cm², Repetition rate 10 Hz. Perform multiple sweeping passes until the carbon lotion is completely vaporized from the skin's surface.
• Step 3 (Laser Toning): Wavelength 1064 nm, Spot size 8 mm, Fluence 1.2 J/cm², 10 Hz. Perform 2 rapid passes to stimulate dermal collagen and even out skin tone.

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Picosecond Head-to-Head: PicoPlus vs. PicoSure vs. PicoWay

Clinics evaluating picosecond platforms should understand the technical differences between the three market-leading devices:

PicoPlus Advantages

• wavelength Versatility: PicoPlus features four distinct wavelengths, including the 595 nm (gold) handpiece designed to target vascular erythema and the 660 nm (ruby-like) handpiece optimized for green and blue tattoo inks.
• High Peak Power: With a peak power of 1.8 Gigawatts (GW), PicoPlus generates higher acoustic shockwaves, allowing it to fracture recalcitrant tattoo ink particles into smaller fragments at lower overall fluences.
• Pulse Duration Stability: Unlike older systems that experience pulse-width elongation (where the pulse stretches from picoseconds to nanoseconds as the system warms up), PicoPlus maintains a stable 450-picosecond duration across prolonged operating cycles.

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What does the MAUDE safety record and the 2026 Clarity II recall show?

Adverse Event Analysis

An analysis of the openFDA MAUDE registry under manufacturer name "Lutronic" yields 93 total reports. The distribution of these events shows a unique pattern compared to other major laser manufacturers:

• Malfunction Reports: 61 cases. These represent reports where the device experienced a technical fault (such as software errors, calibration failures, or cooling system leaks) that required service, but did not result in patient injury.
• Injury Reports: 32 cases. These consist of burns, blisters, post-treatment hyperpigmentation, or localized scarring.
• Death Reports: 0 cases.

The malfunction-dominant split (65% of all reports) indicates a high rate of system-level monitoring. Lutronic devices are engineered with sensitive sensors that log errors and shut down operations before a mechanical or thermal anomaly can injure a patient.

Brand-Specific Breakdown

The distribution of the 93 MAUDE reports by device brand name shows a clear concentration:

• Clarity II: 66 reports (including "CLARITY II" and "CLARITY II LASER SYSTEM"). These are primarily technical malfunctions related to the Intelligent Cooling System (ICS) and the IntelliTrack roller sensor. A smaller subset of 18 reports involve epidermal burns, typically occurring when the handpiece cooling window lost contact with the skin or the scanning tracking sensor did not scale power output correctly.
• DermaV / Derma V: 12 reports. Reports are split between cryogen spray calibration faults and minor post-treatment purpura (bruising) or superficial blistering.
• Genius Intelligent RF Delivery: 2 reports. Involving minor skin pinprick infections or localized swelling post-needling.
• LaseMD Ultra / LaseMD: 2 reports. Involving transient hyperpigmentation.
• Spectra / Hollywood Spectra: 3 reports. Involving post-treatment erythema.

The 2026 Clarity II Class II Recall (Z-1558-2026)

On January 27, 2026, Lutronic Corporation initiated a voluntary recall of the Clarity II Laser System (Model No. 1110200210). The FDA classified this action as a Class II Recall under recall number Z-1558-2026 (recall status: Open, Classified; listed root cause: Device Design).

• The Technical Root Cause: The recall was initiated due to a software bug in the Clarity II's temperature-sensing module. The system's Intelligent Cooling System (ICS) relies on real-time temperature feedback from the skin's surface. The software bug could cause the system to receive incorrect temperature readings or experience a software hang, preventing the cryogen cooling spray from firing.
• The Safety Risk: If the laser fires at high fluence without the synchronous cryogen cooling spray, the patient's epidermis is left unprotected from the thermal energy, significantly increasing the risk of thermal burns, blistering, and subsequent scarring.
• Corrective Actions: Lutronic instructed all clinics using the affected Clarity II model to install the manufacturer's software update, which patches the temperature-module code and implements a hard system-lock that prevents the laser from firing if the cooling sensor does not return a stable signal. The recall status remains Open, Classified in the current FDA database (root cause listed as "Device Design").

For comparative safety profiles of other manufacturers, see our reviews of Candela and Cutera.

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Clinical Trial Evidence

Lutronic's clinical development is documented in several registered trials on ClinicalTrials.gov:

• NCT03415685 (PicoPlus Exploratory Trial): A Cynosure Lutronic-sponsored prospective trial evaluating the PicoPlus picosecond laser for benign pigmented lesions and tattoo removal. The study enrolled 39 subjects and is listed as terminated on ClinicalTrials.gov; quantitative pigment-clearance results were not posted to the public registry.
• NCT03409952 (LaseMD Thulium Study): A Cynosure Lutronic study of the 1927 nm thulium laser for benign pigmented lesions. The study enrolled 20 subjects and is listed as completed; specific recovery-time outcomes were not posted to the public registry.
• NCT03534609 (Genius Neck Treatment): A Cynosure Lutronic trial of the Genius RF microneedling system for neck laxity, enrolling 18 subjects (completed). The Genius platform's real-time impedance feedback is designed to adjust energy delivery to maintain consistent dermal coagulation zones.
• NCT03739398 (Thulium + RF Microneedling Combination): An independent academic study (Yonsei University) enrolling 26 subjects to evaluate combined 1927 nm thulium laser and fractional RF microneedling for facial rejuvenation (completed). It is included here as published combination-therapy evidence rather than a Lutronic-sponsored registration.

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How the 2024 Cynosure Lutronic Merger Under Hahn & Company Changes the OEM Landscape

In January 2024, South Korean private equity firm Hahn & Company, which had previously acquired Lutronic, announced a definitive merger agreement to combine Cynosure and Lutronic into a single global medical aesthetics company.

• Portfolio Integration: The merger combines Cynosure's market-leading Alexandrite hair removal (GentleMax Pro) and picosecond tattoo platforms (PicoSure) with Lutronic's thulium (LaseMD Ultra), vascular Nd:YAG (DermaV), and RF microneedling (Genius) systems.
• Regulatory Synergy: Newer regulatory filings are submitted under the combined entity Cynosure Lutronic Technology Corporation. This integration allows the joint company to leverage a shared global sales, service, and clinical support network, creating a major competitor to AbbVie/Allergan, Candela, and Sisram/Alma.

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FAQ: Common Provider and Patient Questions

Is the Hollywood Spectra carbon peel backed by FDA clearance, and what is it cleared for?

Yes, the Hollywood Spectra laser system is FDA-cleared under K213569. While the "Hollywood Laser Peel" is a specific marketing protocol using a carbon-based lotion, the underlying Q-switched Nd:YAG laser is cleared for surgical and aesthetic applications, including the treatment of melasma, benign pigmented lesions, tattoo removal, and skin resurfacing. The carbon peel protocol is widely supported by clinical literature for exfoliating the skin and temporarily reducing pore size.

Is the 2026 Clarity II recall a safety concern for laser hair removal patients?

The Z-1558-2026 recall is a Class II recall, which indicates that exposure to the device could cause temporary or medically reversible adverse health consequences. The software bug affecting the skin-temperature feature could cause the cooling spray to fail, leading to epidermal burns. Patients should verify with their provider that their Clarity II system has received the manufacturer's software update, which implements a safety lock to prevent the laser from firing if the cooling system is not operating correctly.

How does PicoPlus compare to PicoSure?

Lutronic's PicoPlus is a multi-wavelength picosecond system operating at 1064 nm, 532 nm, 595 nm, and 660 nm using Nd:YAG and dye handpieces. Cynosure's PicoSure (profiled in our PicoSure vs. PicoWay comparison) operates primarily at 755 nm using an alexandrite source. The 755 nm wavelength of PicoSure is highly effective for green and blue inks, while the 1064 nm and 532 nm wavelengths of PicoPlus provide deeper penetration and a high safety profile for darker skin phototypes.

What is the recovery time for a LaseMD Ultra thulium treatment?

LaseMD Ultra is a non-ablative thulium laser, meaning it heats the target tissue without vaporizing the outer skin layer. Recovery times are rapid, with most patients experiencing mild redness and a sandpaper-like skin texture for 24 to 48 hours. Patients can typically apply makeup 24 hours post-procedure. This makes it a popular option for patients seeking pigment correction and mild resurfacing without the prolonged downtime of ablative CO2 lasers.

Which Lutronic laser is best for vascular redness and rosacea?

The DermaV laser system is Lutronic's premier vascular platform. By combining a 532 nm wavelength (highly absorbed by oxyhemoglobin for superficial redness) and a 1064 nm Nd:YAG wavelength (for deeper vascular structures like leg veins), the DermaV allows clinicians to treat a wide range of vascular indications. The system's IntelliTrack technology and integrated cryogen cooling protect the epidermis while delivering energy directly to the target blood vessels, reducing post-treatment purpura (bruising) compared to older vascular lasers.

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Sources

1. FDA Class 2 Device Recall CLARITY II: Recall Z-1558-2026. FDA Recall Database Entry.
2. FDA 510(k) K213569 (Hollywood Spectra): FDA Premarket Notification Database Entry.
3. FDA 510(k) K183566 (Clarity II): FDA Premarket Notification Database Entry.
4. FDA 510(k) K173700 (PicoPlus): FDA Premarket Notification Database Entry.
5. Cynosure and Lutronic Merger Announcement: Cynosure and Lutronic Announce Merger to Create a Leading Global Medical Aesthetics Technology Company. PR Newswire Disclosures.
6. ClinicalTrials.gov Study NCT03415685: Lutronic PicoPlus Exploratory Clinical Trial. ClinicalTrials.gov Entry.
7. ClinicalTrials.gov Study NCT03409952: Lutronic LaseMD Clinical Study for Benign Pigmented Lesions. ClinicalTrials.gov Entry.
8. openFDA MAUDE Database Portal: Manufacturer "Lutronic" search query. openFDA MAUDE Portal.
9. Health Canada Medical Device Advisory: Lutronic Clarity II Temperature Sensing software anomaly. Health Canada Recalls Portal.