The enlighten laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064 nm: The 1064 nm wavelength of the enlighten laser system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).

532 nm: The 532 nm wavelength of the enlighten laser system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

Device Description

The enlighten laser system is a multi-wavelength, pulsed laser system designed for tattoo removal. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm) and pulse widths (750 ps and 2 ns, nominal). The laser, power supplies and control electronics are housed inside a console equipped with a touchscreen control panel. The laser treatment parameters are selected using the control panel. Laser emission is activated by depressing a footswitch. The system is operated using 110 V mains AC power.

An articulated arm with rotational mirror knuckles delivers the laser beam from a laser head inside the console to a handpiece. The handpiece is equipped with a detachable tip that determines the spot size of the laser beam on the treatment surface. Multiple tips are provided to vary the spot size as desired for treatment. The beam of a low-power red diode laser is also transmitted through the arm to provide an aiming beam.

AI/ML Overview

Acceptance Criteria and Device Performance Study for the Enlighten Laser System

This document outlines the acceptance criteria and a detailed description of the study conducted to demonstrate the performance of the enlighten Laser System for tattoo removal.

1. Acceptance Criteria and Reported Device Performance

The core acceptance criteria for the enlighten Laser System, as demonstrated by the clinical study, revolves around the efficacy of tattoo clearing and safety.

Acceptance Criteria Category	Specific Metric	Acceptance Criteria (Implicit from Study Design)	Reported Device Performance
Efficacy (Overall)	Mean improvement in tattoo clearing (Blinded Reviewer Global Assessment)	Statistically significant and clinically meaningful improvement in tattoo clearing compared to baseline, and demonstration of substantial equivalence or superiority to a comparator device.	Overall Mean Improvement: 2.54 (95% CI: 2.13–2.94) for the investigational device vs. 2.17 (95% CI: 1.77–2.57) for the comparator device at 6 weeks post-final treatment. Mean Difference: 0.37 (95% CI: 0.20–0.53) indicating statistically significant (p<0.001) greater clearing for the investigational device.
Efficacy (Pulse Duration)	Mean improvement with ps pulse durations only	Clinically and statistically significant mean improvement.	Mean Improvement: 3.2 (95% CI: 2.54 – 3.86, p<0.001) for ps pulses only. Difference vs. Comparator: 0.7 (95% CI: 0.22 - 1.18, p=0.01) – greatest difference.
	Mean improvement with combined ps and ns pulse durations	Clinically and statistically significant mean improvement.	Mean Improvement: 2.77 (95% CI: 2.23 - 3.32, p<0.001) for combined ps and ns pulses. Difference vs. Comparator: 0.46 (95% CI: 0.10 – 0.81, p=0.015).
	Mean improvement with ns pulse durations only	Clinically and statistically significant mean improvement.	Mean Improvement: 2.3 (95% CI: 1.91 - 2.69, p<0.001) for ns pulses only. Difference vs. Comparator: 0.26 (95% CI: 0.05 - 0.47, p=0.018).
Efficacy (Wavelength)	Mean improvement with 532 nm wavelength	Clinically and statistically significant mean improvement, consistent with overall study population.	Mean Improvement: 2.6 (95% CI: 1.91 - 3.29, p<0.001) for 532 nm wavelength. Consistent with overall study population.
	Mean improvement with 1064 nm wavelength	Clinically and statistically significant mean improvement, consistent with overall study population.	Mean Improvement: 2.53 (95% CI: 2.21 - 2.85, p<0.001) for 1064 nm wavelength. Consistent with overall study population.
Efficacy (Skin Type)	Mean improvement for Fitzpatrick Skin Type I-III	Clinically and statistically significant mean improvement, consistent with overall study population.	Mean Improvement: Consistent with total study population in both investigational and comparator arms. (Specific numerical value for I-III not explicitly stated, but stated as "consistent").
	Mean improvement for Fitzpatrick Skin Type IV-VI	Clinically and statistically significant mean improvement.	Mean Improvement: 2.33 (95% CI: 1.55 – 3.12, p<0.001) for FST IV-VI. Slightly lower than overall study mean, but comparator arm also lower by a similar margin.
Safety	Incidence and severity of adverse events	Tolerable treatments, equivalent adverse event profiles to comparator device, and no serious adverse events.	Pain Scores: Similar with both devices (mean 4.1 vs. 4.4 on 0-9 scale). Common AEs: Expected erythema, edema, and pin-point bleeding in both arms. Serious AEs: No serious adverse events reported. Subgroup AEs: Equivalent adverse event profiles for all subgroups; no significant differences in incidence/severity.
Additional Data	Mean tattoo clearance for unilateral picosecond-only treatments (12 weeks post-final)	Consistent with 6-week picosecond-only data from the main study.	Mean Clearance: 3.4 for 19 additional unilateral picosecond-only treatments at 12 weeks post-final treatment, consistent with the 3.2 clearance rating from the 6-week data. AEs: edema and erythema consistent with main study; no unexpected or serious adverse events.
Substantial Equivalence	Overall comparison to predicate devices	Demonstrate substantial equivalence to predicate devices in terms of indications for use, technical specifications, operating performance features, and general design, with equivalent or superior safety and effectiveness.	The study concluded that the enlighten laser system is substantially equivalent to the predicate devices for the requested indication based on safe and effective tattoo removal, with the investigational device showing statistically significant (p<0.001) greater clearing than the comparator.

2. Sample Size and Data Provenance

Test Set Sample Size: Forty-two (42) subject tattoos were initially enrolled, with forty-one (41) completing the study (1 lost to follow-up).
Data Provenance: The study was a multicenter prospective clinical study. The country of origin is not explicitly stated in the provided text, but the FDA submission context suggests it was likely conducted in the US or in a manner compliant with US regulatory standards.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: A panel of independent, blinded reviewers (plural, implying more than one) was used. The exact number is not specified, but typically, panels consist of 3 or more experts.
Qualifications of Experts: The experts were identified as "dermatologists." Further details on their years of experience or board certification are not provided in this summary.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated as a formal consensus or voting model (e.g., 2+1, 3+1). However, "Blinded review of baseline and post-treatment tattoo photographs resulted in a clinically and statistically significant mean improvement of..." suggests that the individual assessments of the blinded reviewers were aggregated and analyzed statistically (e.g., averaged) to produce the reported improvement scores rather than a strict adjudication for each case to reach a single consensus ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Yes, a comparative effectiveness study was performed. The study compared the "enlighten Laser System" (investigational device) against a "comparator Q-Switched Nd:YAG laser."

Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: This metric is not applicable as the study was not evaluating an AI system or human-in-the-loop performance. It was a direct comparison of two laser devices, not an AI-assisted diagnostic or treatment planning tool. The "readers" here were medical dermatologists assessing photographic evidence of treatment outcome.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. The enlighten Laser System is a physical medical device (laser system) and its performance was assessed through a clinical study involving human patients and laser treatments administered by healthcare professionals, with outcomes assessed by human expert reviewers.

7. Type of Ground Truth Used

The ground truth for assessing efficacy was established through expert consensus (or aggregated expert assessment) of photographic evidence. Blinded dermatologists reviewed standardized photographs taken at baseline and 6 weeks post-final treatment to assess "tattoo clearing."

Safety ground truth was established by investigator assessments at each visit and through subject-reported phone surveys for adverse events.

8. Sample Size for the Training Set

The provided document describes a clinical study to assess the safety and efficacy of the enlighten Laser System. It does not mention any "training set" in the context of an algorithm or machine learning model. The study described is a clinical trial to evaluate the device itself.

9. How Ground Truth for the Training Set was Established

As there is no mention of an algorithm or machine learning component, there is no "training set" or ground truth establishment method for it described in this document. The clinical study served to validate the performance of the physical laser device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 6, 2014

Cutera Incorporated Mr. Bradley Renton Vice President, Regulatory and Medical Affairs 3240 Bayshore Boulevard Brisbane, California 94005

Re: K140727

Trade/Device Name: enlighten Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: October 28, 2014 Received: October 29, 2014

Dear Mr. Renton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Section 4 Indications for Use

510(k) Number (if known): K140727

Device Name: enlighten Laser System

Indications for Use:

The enlighten laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064 nm

The 1064 nm wavelength of the enlighten laser system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).

532 nm

The 532 nm wavelength of the enlighten laser system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

Prescription Use xx (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Section 5 510(K) Summary

This 510(K) Summary of safety and effectiveness for the enlighten laser system is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant:	Cutera, Inc.
Address:	3240 Bayshore Blvd., Brisbane, CA 94005
Contact Person:	Bradley Renton
Telephone:	415-657-5568 - phone
Fax:	415-715-3568 - fax
Email:	brenton@cutera.com
Preparation Date:	October 21, 2014
Device Trade Name:	enlighten Laser System
Common Name:	Dermatology Laser
Classification Name:	Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878.4810
Legally MarketedPredicate Devices:	Cutera Q-Switch Laser System (K102954)Quanta System Q-Plus T (K073549)Cynosure PicoSure (K121346)
Device Description:	The enlighten laser system is a multi-wavelength, pulsed lasersystem designed for tattoo removal. A key feature of the device isits ability to produce multiple laser wavelengths (1064 nm and 532nm) and pulse widths (750 ps and 2 ns, nominal). The laser, powersupplies and control electronics are housed inside a consoleequipped with a touchscreen control panel. The laser treatmentparameters are selected using the control panel. Laser emission isactivated by depressing a footswitch. The system is operated using110 V mains AC power.An articulated arm with rotational mirror knuckles delivers the laserbeam from a laser head inside the console to a handpiece. Thehandpiece is equipped with a detachable tip that determines thespot size of the laser beam on the treatment surface. Multiple tipsare provided to vary the spot size as desired for treatment. Thebeam of a low-power red diode laser is also transmitted through thearm to provide an aiming beam.
Intended Use:	The enlighten laser system is intended for use in surgical andaesthetic applications in the medical specialties of dermatology andgeneral and plastic surgery.
Specific Indications:	1064 nm:The 1064 nm wavelength of the enlighten laser system is indicatedfor tattoo removal for dark colored tattoo inks and for multicoloredtattoos containing dark colored tattoo inks on patients with all skintypes (Fitzpatrick I-VI).
	532 nm:The 532 nm wavelength of the enlighten laser system is indicatedfor tattoo removal for lighter colored tattoo inks, including red andyellow inks, on patients with Fitzpatrick skin types I-III.
Performance Data:	IEC 60601-1 Medical Electrical Equipment - Part 1: GeneralRequirements for Safety
	IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: GeneralRequirements for Safety - Collateral Standard: ElectromagneticCompatibility
	Nova Software Verification and Validation Testing Report(V0083 r1)
Results of ClinicalStudy:	An IRB-approved multicenter prospective clinical study wasconducted to assess the safety and efficacy of the enlighten lasersystem for tattoo removal. Forty-two subject tattoos of black/blueink, alone or with other colors, older than one year and 2 to 12square inches in size were enrolled. Forty-one subject tattooscompleted the study with 1 lost to follow-up. Subject tattoos weredivided into 2 portions for treatment with the Cutera InvestigationalQ-Switched Nd:YAG laser and a comparator Q-switched Nd:YAGlaser respectively, based on randomization assignment. Subjecttattoos received 2 to 3 treatments with both laser systemsperformed 6 weeks apart. Subject tattoos were followed for 6 weeksfollowing final laser treatment.
	Standardized photographs were taken at baseline and 6 weeksfollowing the final treatment. Primary efficacy assessments wereperformed through review of tattoo photographs taken at baselineand 6 weeks post-final treatment by a panel of independent, blindedreviewers (dermatologists). Safety was assessed by the investigatorat each visit and via phone surveys (subject reporting) conducted at3 and 14 days following each laser treatment.
	Blinded review of baseline and post-treatment tattoo photographsresulted in a clinically and statistically significant mean improvementof 2.54 (95% CI: 2.13–2.94) and 2.17 (95% CI: 1.77–2.57) for theCutera Investigational device and comparator device, respectively, a6 weeks post-final treatment. The mean difference in reviewer'sglobal assessment of improvement scores between theInvestigational and comparator devices was 0.37 (95% CI: 0.20–0.53), indicating that the Investigational device resulted in moreclearing than the comparator device at 6 weeks following 2 to 3

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Attachment 5 510(K) Summary

treatment sessions. This result was statistically significant (p<0.001).

All subjects tolerated treatments well and pain scores were similar with both the investigational and comparator devices (mean pain scores of 4.1 (0.9-0) and 4.4 (0-9) respectively). As expected, subjects experienced erythema, edema and pin-point bleeding in both treatment arms following laser treatment. No serious adverse events were noted.

Subgroup analysis was performed looking at pulse duration, wavelength, and patient skin type. The first subgroup analysis divided subjects into cohorts based on pulse duration: (1) subjects treated with the investigational device using ps pulse durations only; (2) subjects treated with a combination of ps and ns pulse durations in the investigational arm: (3) subjects treated only with ns pulse durations in the investigational arm. The second subgroup analysis divided subjects into cohorts based upon treatment wavelength: (1) treatments were administered using the 532 nm wavelength; (2) only the 1064 nm wavelength was used during laser treatments. The final subgroup analysis divided subjects into cohorts based upon patient skin type: (1) Fitzpatrick skin type IV-VI; (2) Fitzpatrick skin type I-III.

Blinded Reviewer assessment of tattoo clearing at 6 weeks posttreatment for subgroup analysis 1 (Pulse Duration) for the subjects in cohort 1 (treated only with ps pulses) resulted in a clinically and statistically significant mean improvement score of 3.2 (95% Cl: 2.54 – 3.86, p<0.001) in the investigational arm. Subjects in cohort 2 (treated with combination of ps and ns pulses) had a clinically and statistically significant mean improvement score of 2.77 (95% Cl: 2.23 - 3.32, p<0.001). Subjects assigned to cohort 3 (ns pulse only) had a clinically and statistically significant mean improvement score of 2.3 (95% Cl: 1.91 - 2.69, p<0.001). In all cohorts, the investigational device showed a statistically significant higher clearance than the comparator device, with ps pulses only having the greatest difference [0.7 (95% CI: 0.22 - 1.18, p=0.01)], followed by ps and ns [0.46 (95% Cl: 0.10 – 0.81, p=0.015)], and then ns pulses only [0.26 (95% Cl: 0.05 - 0.47, p=0.018)].

Blinded Reviewer assessment results for subgroup analysis 2 (Wavelength) for subjects in cohort 1 of subgroup 2, who were treated with the 532 nm wavelength of the investigational and comparator devices, and cohort 2 of subgroup 2, who were treated with only the 1064 nm wavelength of the investigational and comparator devices, demonstrated clinically and statistically significant mean improvement scores for the investigational treatment arm of 2.6 (95% Cl: 1.91 - 3.29, p<0.001) and 2.53 (95% CI: 2.21 - 2.85, p<0.001) respectively based on blinded reviewers' photographic assessments of tattoo clearing at 6 weeks posttreatment. These improvement scores were consistent with the overall study population.

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Attachment 5 510(K) Summary

Subgroup analysis was performed based on patient skin type (subgroup analysis 3). At 6 weeks post-final treatment, subjects in cohort 1 of subgroup 3 had a clinically and statistically significant mean improvement score of 2.33 (95% Cl: 1.55 – 3.12. p<0.001) in the investigational arm based on blinded reviewers' photographic assessment. The mean clearing score for the investigational arm in this cohort is slightly lower than the overall study population; however, the mean score in the comparator arm for this cohort was also 0.5 less than that of the comparator arm for the total study population. Subjects with FST I-III had mean tattoo clearing scores in the investigational and comparator arms consistent with the total study population. Safety data showed equivalent adverse event profiles for subjects for both patient cohorts. There were no significant differences in the incidence and severity of adverse events occurring in the investigational treatment arm versus the comparator arm.

Data for 19 additional unilateral picosecond-only treatment sessions was also presented. The blinded reviewers' photographic assessments of subject tattoos at 12 weeks post-final treatment relative to baseline resulted in a mean tattoo clearance rating of 3.4. This clearance is consistent with the 3.2 clearance rating achieved in subjects in cohort 1 subgroup analysis 1, who also received picosecond treatments only. All subjects experienced edema and erythema following laser treatment; the incidence and severity were consistent with those observed in the comparator-controlled clinical study. No unexpected or serious adverse events were reported.

The treatment outcomes observed were consistent with the results of published studies for tattoo removal with nanosecond QS lasers. The comparative results between the investigational and active comparator arms of this study showed substantially equivalent outcomes and adverse events for both treatment arms.

Tattoo removal with the enlighten laser system was found to be safe and effective allowing the conclusion that the enlighten laser system is substantially equivalent to the predicate devices for the requested indication.

Summary of Technological Characteristics:

Conclusion:

The enlighten laser system is substantially equivalent to the predicate devices in terms of indications for use, technical specifications, operating performance features and general design.

See table below

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Section 5 510(K) Summary

	enlighten Laser System	Cutera Q-Switch LaserSystem ( K102954)	Quanta System Q-Plus T(K073549)	Cynosure PicoSure(K121346)
Wavelength	1064 nm Nd:YAG laser532 nm Nd:YAG laser	1064 nm Nd:YAG laser532 nm Nd:YAG laser	1064 nm Nd:YAG laser532 nm Nd:YAG laser	755 nm Alexandrite laser
Max Pulse Energy	1064 nm: 600 mJ532 nm: 300 mJ	1064 nm: 1600 mJ532 nm: 500 mJ	1064 nm: 1000 mJ532 nm: 500 mJ	200 mJ
Max Fluence	1064 nm: 10 J/cm²532 nm: 2.5 J/cm²	1064 nm: 12 J/cm²532 nm: 5 J/cm²	1064 nm: 22 J/cm²532 nm: 11 J/cm²	6.37 J/cm²
Pulse Duration(nominal)	750 ps or 2 ns	5-20 ns	6 ns	≤ 900 ps
Spot Size	2, 3, 4, 6 or 8 mm	2-8 mm	Up to 6 mm	Zoom 2-6 mm; fixed 2, 3, 4, 6, 8or 10 mm
Output Mode	Pulsed	Pulsed	Pulsed	Pulsed
Repetition Rate	≤ 10 Hz or single shot	≤ 10 Hz or single shot	≤ 10 Hz or single shot	≤ 10 Hz or single shot
Laser Media	Q-switched Nd:YAG laser	Q-switched Nd:YAG laser	Q-switched Nd:YAG laser	Q-switched Alexandrite laser
User Interface	Push-button control or LCDcolor touchscreen	Push-button control or LCDcolor touchscreen	Push-button control or LCDcolor touchscreen	Push-button control or LCDcolor touchscreen
Treatment BeamActivation	Footswitch	Footswitch	Footswitch	Footswitch
Delivery System	Articulated arm with user-detachable handpiece tips	Articulated arm with user-detachable handpiece tips	Articulated arm with user-detachable handpiece tips	Articulated arm with user-detachable handpiece tips
Aiming Beam	635 nm	635-655 nm	635 nm	630-690 nm
Handpiece Tips (HowSupplied)	Non-sterile, reusable,cleanable	Non-sterile, reusable,cleanable	Non-sterile, reusable,cleanable	Non-sterile, reusable,cleanable

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.