The enlighten III 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 III laser system is indicated for:

treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
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 III laser system is indicated for:

treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III

670 nm:
The 670 nm wavelength of the enlighten III laser system is indicated for treatment of benign pigments with Fitzpatrick skin types I-III.

Device Description

The enlighten III laser system is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce multiple laser wavelengths and pulse widths (1064 and 532 nm: 750 ps and 2 ns; 670 nm: 660 ps).

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. 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 an optical zoom assembly that determines the spot size of the laser beam on the treatment surface. The beam of a low-power diode laser is also transmitted through the arm to provide an aiming beam.

AI/ML Overview

Here's an analysis of the acceptance criteria and study proving the device's performance, based on the provided text:

Device: enlighten III Laser System
Indications for Use (670 nm wavelength): Treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with pre-defined numerical targets. Instead, the study aims to demonstrate safety and efficacy, implicitly establishing that a certain level of improvement and safety is acceptable for market clearance. Based on the study results, the implied acceptance criteria for efficacy appears to be achieving statistically significant lightening (>50% improvement) and high patient satisfaction for the treatment of benign pigmented lesions. Safety is assessed by the absence of serious adverse events and good tolerability.

Feature / Criteria	Implied Acceptance Standard (from study results)	Reported Device Performance (670 nm wavelength)
Efficacy
>50% BPL Lightening (Cohort 1)	Achieve statistically significant improvement.	Observed in 66% of treated BPL areas (median improvement score of 2.00, statistically significant: p<0.0001).
>50% BPL Lightening (Cohort 2)	Achieve statistically significant improvement.	Observed in 74% of treated subjects (median improvement score of 2.33, statistically significant: p<0.001).
Patient Satisfaction (Cohort 1)	High percentage of subjects satisfied/extremely satisfied and willing to recommend/repeat treatment.	96% of subjects were satisfied or extremely satisfied, and would repeat the treatment or recommend it to others.
Patient Satisfaction (Cohort 2)	High percentage of subjects satisfied/extremely satisfied and willing to recommend/repeat treatment.	85% of subjects were satisfied or extremely satisfied, 90% would repeat the treatment, and 95% would recommend it to others.
Safety
Pain levels	Tolerable pain levels.	Mean pain scores: Cohort 1 (1.0 ± 0.2 [1-2]); Cohort 2 (0.96 ± 0.37 [0-2]) on a 10-point scale. Considered "tolerated well."
Adverse Events	No serious adverse events; expected minor effects resolve.	All subjects experienced minor erythema, edema, and lesion frosting immediately. Most experienced mild crusting. All adverse effects resolved or improved during the study period with no required intervention. No serious adverse events were noted.

2. Sample Size Used for the Test Set and Data Provenance

The study was a prospective clinical study. The document does not specify the country of origin of the data, but it is a US FDA 510(k) submission, suggesting the study likely took place in the US or followed international standards acceptable to the FDA.

Total Enrolled: 48 subjects with Fitzpatrick skin types I-III and benign pigmented lesions.
Cohort 1: 25 subjects with 32 subject-treatment-areas. (For analysis, a dataset of 25 observations was created by randomly selecting one treatment area per subject, 100 times).
Inter-cohort subjects: 3 additional subjects with 5 subject-treatment-areas.
Cohort 2: 20 subjects with a single subject-treatment-area.
Completed Study: 46 subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Three independent dermatologists.
Qualifications: "Independent dermatologists" – further specific qualifications (e.g., years of experience) are not provided in the document.

4. Adjudication Method for the Test Set

The adjudication method involved a "blinded assessment of improvement (clearing)" completed by the three independent dermatologists. The description provides details on consistency:

For Cohort 1, reviewers were consistent (kappa of 0.874) and accurate (kappa of 0.833) in identifying baseline and post-treatment photographs. 78% of photographs were scored identically or within one grade difference.
For Cohort 2, reviewers were consistent (kappa of 1.0) and accurate (kappa of 1.0). 95% of photographs were scored identically or within one grade difference.
Overall (presumably for all data by the three reviewers), scores were an exact match in 16% of BPL photographs, and within one grade difference in 79% of photographs.

This indicates an expert consensus approach, implicitly averaging or considering the predominant score for analysis given the high consistency. It isn't a strict "2+1" or "3+1" where a specific number of agreements is required; rather, the agreement level itself is reported as favorable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study evaluated the standalone performance of the enlighten III laser system for lesion clearing and safety, not how human readers' performance improved with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This study is for a laser system (medical device), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" as it applies to AI/software is not relevant here. The laser system itself is the "device" being evaluated in its standalone clinical application.

7. The Type of Ground Truth Used

The ground truth for efficacy was established through expert consensus based on blinded review of standardized photographs. The experts assessed "improvement (clearing)" of benign pigmented lesions. Safety ground truth was based on reported pain levels and observed/recorded adverse events by investigators.

8. The Sample Size for the Training Set

This document describes a clinical study for a laser device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. The clinical study itself serves as the primary evidence for safety and efficacy for the device. If the question implies a "training set" for the clinical practice of using the device, that is not specified in this regulatory document.

9. How the Ground Truth for the Training Set Was Established

As stated above, there is no training set in the context of AI/ML for this device.

Summary

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

October 28, 2016

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

Re: K160488

Trade/Device Name: enlighten III 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 5, 2016 Received: October 6, 2016

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Sincerely,

Jennifer R. Stevenson -A

For 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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Indications for Use

510(k) Number (if known) K160488

Device Name enlighten III Laser System

Indications for Use (Describe)

The enlighten III 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 III laser system is indicated for:

· treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
• 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 III laser system is indicated for:

· treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III

670 nm:

The 670 nm wavelength of the enlighten III laser system is indicated for treatment of benign pigments with Fitzpatrick skin types I-III.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 510(K) Summary

This 510(K) Summary of safety and effectiveness for the enlighten III 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
	415-657-5568 – phone415-715-3568 – faxbrenton@cutera.com
Preparation Date:	October 25, 2016
Device Trade Name:	enlighten III Laser System
Common Name:	Dermatology Laser
Classification Name:	Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878.4810
Legally MarketedPredicate Devices:	Cutera enlighten Laser System (K133945 and K140727)Cynosure PicoSure (K121346)Quanta System Q-Plus T (K073549)Cynosure RevLite (K133254)
Device Description:	The enlighten III laser system is a multi-wavelength, pulsed lasersystem. A key feature of the device is its ability to produce multiplelaser wavelengths and pulse widths (1064 and 532 nm: 750 ps and2 ns; 670 nm: 660 ps).The laser, power supplies, and control electronics are housedinside a console equipped with a touchscreen control panel. Thelaser treatment parameters are selected using the control panel.Laser emission is activated by depressing a footswitch. Anarticulated arm with rotational mirror knuckles delivers the laserbeam from a laser head inside the console to a handpiece. Thehandpiece is equipped with an optical zoom assembly thatdetermines the spot size of the laser beam on the treatmentsurface. The beam of a low-power diode laser is also transmittedthrough the arm to provide an aiming beam.
Indications for Use:	1064 nmThe 1064 nm wavelength of the enlighten III laser system isindicated for:treatment of benign pigmented lesions on patients with allskin types (Fitzpatrick I-VI) tattoo removal for dark colored tattoo inks and formulticolored tattoos containing dark colored tattoo inks on

patients with all skin types (Fitzpatrick I-VI)

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532 nm

The 532 nm wavelength of the enlighten III laser system is indicated for:

treatment of benign pigmented lesions on patients with . Fitzpatrick skin types I-III
tattoo removal for lighter colored tattoo inks, including red . and yellow inks, on patients with Fitzpatrick skin types I-III

670 nm

The 670 nm wavelength of the enlighten III laser system is indicated for treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.

IEC 60601-1 Medical Electrical Equipment - Part 1: General Performance Data: Requirements for Safety (Edition 3.1. 2012), including:

. IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements for Safety - Collateral Standard: Usability (Edition 3.1, 2013) - Test Report Attachment 4
. IEC 62366 Medical Devices - Application of Usability Engineering to Medical Devices (Edition 1.1, 2014) - Test Report Attachment 5
IEC 60601-2-22 Medical Electrical Equipment Part 2: . Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment (Edition 3.1, 2012) – Test Report Attachment 6
. IEC 60825-1 Safety of Laser Products - Part 1: Equipment Classification and Requirements (Edition 2.0, 2007) - Test Report Attachment 7

The product also fulfills the requirements of AAMI/ANSI ES60601-1:2005+A2 (R2012) + A1.

IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility (Edition 3, 2007)

enlighten III Software Verification and Validation Testing Report (V0141 r2)

An IRB-approved prospective clinical study was conducted to Results of Clinical Study: assess the safety and efficacy of the 670 nm wavelength of the enlighten III laser system for the treatment of benign pigmented lesions.

Forty-eight subjects with Fitzpatrick skin types I-III diagnosed with benign pigmented lesions of the hands, body, or face were enrolled and received a single picosecond 670 nm treatment. Subjects were enrolled in two primary cohorts: 25 subjects with 32 subjecttreatment-areas were enrolled in cohort 1; 3 additional subjects with

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5 subject-treatment-areas were enrolled between the two primary cohorts; and 20 subjects with a single subject-treatment-area were enrolled in cohort 2. Forty-six subjects completed the study; one patient was lost to follow-up from the 3 subjects enrolled between the two primary cohorts; and one subject was lost to follow-up from the 2nd cohort.

The first cohort of 25 subjects and the 3 additional subjects were enrolled under protocol Ver. 1, and standardized photographs were taken at baseline and 12 weeks following treatment. The 200 cohort of 20 subjects was enrolled under protocol Ver. 2, and standardized photographs were taken at baseline and 6 weeks following treatment. Blinded assessment of improvement (clearing) in the benign pigmented lesions was completed by three independent dermatologists. Pain levels during treatment and adverse events were recorded during all visits.

For cohort 1, to create a dataset with 25 observations, one from each subject, a single treatment area was randomly selected from each subject for whom multiple treatments were done. This dataset with 25 observations was then created 100 times using a different randomization each time. Greater than 50% BPL lightening was observed in 66% of treated BPL areas, and the median improvement score of 2.00 was statistically significant (one-sample Wilcoxon Signed Test, 95% Cl: 1.67 - 2.67, p<0.0001). Investigator and subject subjective assessments of improvement were consistent with the blinded review.

For cohort 2, greater than 50% BPL lightening was observed in 74% of treated subjects, and the median improvement score of 2.33 was statistically significant (one-sample Wilcoxon Signed Test, 95% CI: 1.67 - 2.67, p<0.001). The mean and standard deviation were 2.12 ± 0.61. Investigator and subject subjective assessments of improvement were consistent with the blinded review.

For cohort 1, the reviewers were consistent (kappa of 0.874) and accurate (kappa of 0.833) in identification of the baseline and posttreatment photographs. Seventy-eight percent of the subject photographs were scored identically or within one grade difference. For cohort 2, the reviewers were consistent (kappa of 1.0) and accurate (kappa of 1.0) in identification of the baseline and posttreatment photographs. Ninety-five percent of the subject photographs were scored identically or within one grade difference. The 3 blinded reviewers' scores were an exact match in 16% of BPL photographs, and in 79% of photographs the 3 scores were within one grade difference.

For cohort 1, 96% percent of subjects were satisfied or extremely satisfied with the results of a single treatment and would repeat the treatment or recommend it to others. For cohort 2, 85% of subjects were satisfied or extremely satisfied with the results of a single treatment, 90% percent of the subjects would repeat the treatment,

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and 95% would recommend it to others.

All subjects tolerated treatments well (cohort 1, mean pain score of 1.0 ± 0.2 [1-2]; cohort 2, mean pain score of 0.96 ± 0.37 [0-2] on a 10-point scale). As expected, all subjects experienced minor erythema, edema, and lesion frosting immediately following laser treatment, and most experienced mild crusting of treated lesions. All adverse effects resolved or improved during the study period with no required intervention. No serious adverse events were noted.

Treatment of benign epidermal pigmented lesions with the 670 nm output wavelength of the enlighten III laser system was found to be safe and effective, with minimal discomfort and adverse effects, allowing the conclusion that the enlighten III laser system is substantially equivalent to the predicate devices for the requested indications.

Summarv of The Cutera enlighten III laser system has the same intended use Technological and indications for use, as well as the same or very similar Characteristics: technological characteristics and operating principles, as the Cutera enlighten laser system (primary predicate: K133945 and K140727), Cynosure PicoSure (K121346), Quanta System Q-Plus T (K073549), and Cynosure RevLite (K133254). The enlighten III device design and components are very similar to those of the previously cleared enlighten laser system, where the only key difference is the addition of components to produce the 670 nm wavelength. The device design and components are also very similar to those of the Cynosure PicoSure, Quanta System Q-Plus T, and Cynosure RevLite predicates. For each of these systems:

the user interface is located at the front/top of the console; ●
. the treatment handpiece is attached to an articulating arm that is connected to the main system console;
the laser output at each wavelength is generated within the laser chassis and delivered to the skin through the handpiece attached to the articulated arm; and
. the handpiece allows the spot size on the skin to be adjusted according to device specifications.

Each system thus consists of an articulating arm and attached handpiece, as well as an electrically powered system console that produces the laser energy and houses the software and user interface.

The enlighten III laser system provides similar key design aspects, including the same or similar spot sizes, laser wavelengths, pulse widths, and laser types as its predicate devices. The repetition rate of the enlighten III laser system is the same as or within the repetition rate range of the predicate devices. Further, each of the devices presents a range of spot sizes to allow the user to choose the most appropriate spot size

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for each patient. Therefore, the minor differences do not raise any new safety or effectiveness questions, because the enlighten III parameters are the same as or within the range of the predicates.

See Table 5A below.

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

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Section 5 510(K) Summary

Table 5A—Technical Specification Comparison

	enlighten III Laser System(K160488 current submission)	Cutera enlighten Laser System(K133945 and K140727)	Quanta System Q-Plus T(K073549)	Cynosure PicoSure(K121346)	Cynosure RevLite(K133254)
Wavelength	1064 nm532 nm670 nm	1064 nm532 nm	1064 nm532 nm694 nm	755 nm	1064 nm532 nm585 nm (with optional dye handpiece)650 nm (with optional dye handpiece)
Max Pulse Energy	1064 nm: 600 mJ532 nm: 300 mJ670 nm: 125 mJ	1064 nm: 600 mJ532 nm: 300 mJ	1064 nm: 1000 mJ532 nm: 500 mJ694 nm: 1000 mJ	200 mJJ	1064 nm: 1.6 J532 nm: 500 mJ585 nm: unknown650 nm: 170 mJ
Max Fluence	1064 nm: 10 J/cm²532 nm: 2.5 J/cm²670 nm: 4.0 J/cm²	1064 nm: 10 J/cm²532 nm: 2.5 J/cm²	1064 nm: 22 J/cm²532 nm: 11 J/cm²694 nm: 25 J/cm²	6.37 J/cm²	1064 nm: 12 J/cm²532 nm: 5 J/cm²585 nm: 10 J/cm²650 nm: 6 J/cm²
Pulse Duration(nominal)	1064 nm: 750 ps or 2 ns532 nm: 750 ps or 2 ns670 nm: 660 ps	750 ps or 2 ns	1064 nm: 6 ns532 nm: 6 ns694 nm: 30 ns	450 - 900 ps	1064 nm: 7-20 ns532 nm: 7-20 ns585 nm: <7 ns650 nm: <7 ns
Spot Size	1064 nm and 532 nm: 2, 3, 4,5, 6, 7, and 8 mm670 nm: 2, 3, 4, 5, and 6 mm	2, 3, 4, 6, or 8 mm	Up to 6 mm	Zoom 2-6 mm; fixed 2, 3, 4, 6, 8or 10 mm	Zoom 2-8.5 mm
Output Mode	Pulsed	Pulsed	Pulsed	Pulsed	Pulsed
Repetition Rate	1, 2, 3.3, 5, and 10 Hz orsingle shot	≤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 andQ-switched Ruby laser	Q-switched Alexandrite laser	Q-switched Nd:YAG laser
User Interface	Push-button control or LCD colortouchscreen	Push-button control or LCD colortouchscreen	Push-button control or LCD colortouchscreen	Push-button control or LCD colortouchscreen	Push-button control or LCD colortouchscreen
Treatment BeamActivation	Footswitch	Footswitch	Footswitch	Footswitch	Footswitch
Delivery System	Articulated arm with laserhandpiece	Articulated arm with laserhandpiece	Articulated arm with laserhandpiece	Articulated arm with laserhandpiece	Articulated arm with laser handpiece
Aiming Beam	≤1 mW Max at 450 nm	≤1 mW Max at 635 nm	635 nm	630-690 nm	650 nm
Handpiece (HowSupplied)	Non-sterile, reusable, cleanable	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.