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)
treatment of acne scars on patients with Fitzpatrick skin types II-V when used with the Micro Lens Array handpiece attachment

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-IV
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
tattoo removal for lighter colored tattoo inks, including green and blue inks, on patients with Fitzpatrick skin types II-IV

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 and 2 ns).

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, as well as an optional Micro Lens Array handpiece attachment, which can be attached to the distal end of the handpiece to fractionate the treatment beam. The beam of a low-power blue diode laser is also transmitted through the arm to provide an aiming beam.

AI/ML Overview

This document describes the Cutera enlighten III Laser System and its expanded indications for use, specifically for the treatment of acne scars with the Micro Lens Array handpiece attachment.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Primary Efficacy Endpoint: Demonstrate improvement in acne scars.	93.9% of subjects showed improvement in acne scars as assessed by correct identification of the temporal order of randomized baseline and follow-up visit images by at least two of three blinded dermatologist evaluators.
Secondary Efficacy Endpoint: Patient satisfaction with treatment results.	76% of subjects reported being very satisfied or satisfied with the treatment results. 91% of subjects would likely have the investigational treatment again.
Safety Endpoints: No unexpected adverse events.	The safety endpoints of the clinical study were met, with subjects experiencing no unexpected adverse events.

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

Sample Size: 33 subjects
Data Provenance: The study was a prospective, multicenter, pivotal study. The country of origin of the data is not explicitly stated, but as the submission is to the U.S. FDA, it is generally assumed to be from the U.S. or international sites adhering to similar regulatory standards.

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

Number of Experts: Three blinded dermatologist evaluators.
Qualifications of Experts: They were identified as "dermatologist evaluators," implying they are medical doctors specializing in dermatology. No specific details on their years of experience are provided.

4. Adjudication Method for the Test Set

Adjudication Method: "at least two of three blinded dermatologist evaluators." This indicates a 2/3 consensus or majority rule for assessing improvement.

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

A MRMC comparative effectiveness study was not directly reported in terms of comparing human readers with and without AI assistance. The study described is a clinical trial assessing the device's efficacy and safety for treating acne scars; it is not focused on an AI component for diagnosis or evaluation by human readers.

6. Standalone (Algorithm Only) Performance Study

A standalone algorithm-only performance study was not applicable/not performed as this device is a laser system for treatment, not an AI diagnostic or assistive algorithm.

7. Type of Ground Truth Used

The ground truth for the efficacy endpoint (improvement in acne scars) was established by expert consensus (at least two of three blinded dermatologist evaluators) based on the visual assessment of randomized baseline and follow-up images.
Patient satisfaction and willingness to undergo treatment again serve as a form of patient-reported outcomes data.

8. Sample Size for the Training Set

The document describes a clinical study for the validation of the device's efficacy and safety for a new indication. It does not mention a "training set" in the context of an algorithm. The 33 subjects are part of the evaluative study, not a training set for an AI model.

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

Not applicable, as there is no mention of a "training set" for an algorithm in this submission. The 33 subjects were part of the prospective clinical study to assess the device's performance for the expanded indication.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is a seal with an eagle and text around it. To the right of the seal, there is a blue square with the letters "FDA" in white. To the right of the blue square, there is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Cutera, Inc. Julia Brown Manager, Regulatory Affairs 3240 Bayshore Blvd. Brisbane, California 94005

December 12, 2018

Re: K182997

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 29, 2018 Received: October 30, 2018

Dear Julia Brown:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Neil R Ogden Digitally signed by Neil R Date: 2018.12.12 13:52:37 - S 001500

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) K182997

Device Name Cutera 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)

· treatment of acne scars on patients with Fitzpatrick skin types II-V when used with the Micro Lens Array handpiece attachment

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-IV
· 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:

70 nm wavelength of the enlighten family of 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 green and blue inks, on patients with Fitzpatrick skin types II-IV

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

X 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:	Julia Brown
	415-657-5575 - phone415-715-3575 - faxjbrown@cutera.com
Preparation Date:	December 11, 2018
Device Trade Name:	enlighten III Laser System
Common Name:	Dermatology Laser
Classification Name:	Powered Laser Surgical Instrument, GEX, 21 CFR 878.4810
Legally MarketedPredicate Devices:	Cutera enlighten III Laser System (K172077)Syneron Candela PicoWay Laser System (K170597)
Legally MarketedReference Device:	Cynosure PicoSure Workstation (K173199)
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 and 2 ns).
	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.
	An articulated 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, as well as an optional Micro Lens Array handpieceattachment, which can be attached to the distal end of thehandpiece to fractionate the treatment beam. The beam of a low-power blue diode laser is also transmitted through the arm toprovide an aiming beam.
Indications for Use:	The enlighten III laser system is intended for use in surgical andaesthetic applications in the medical specialties of dermatology andgeneral and plastic surgery.
	1064 nmThe 1064 nm wavelength of the enlighten III laser system isindicated for:

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Section 5 510(K) Summary

. 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)
treatment of acne scars on patients with Fitzpatrick skin . types II-V when used with the Micro Lens Array handpiece attachment

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-IV
. 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
. tattoo removal for lighter colored tattoo inks, including green and blue inks, on patients with Fitzpatrick skin types II-IV

Performance Data: There are no changes to the software, electrical safety, electromagnetic compatibility, or biocompatibility associated with this submission. Therefore, no additional performance testing is necessary for the expanded indications for use.

Results of Clinical An IRB-approved, open-label, prospective, multicenter, pivotal Study: study was conducted to assess the safety and efficacy of the Cutera enlighten III laser system with the Cutera Micro Lens Array handpiece attachment for the treatment of acne scars.

Thirty-three subjects received treatment with the 1064 nm laser. 93.9% of subjects showed improvement in acne scars as assessed by correct identification of the temporal order of randomized baseline and follow-up visit images by at least two of three blinded dermatologist evaluators.

Based on subject questionnaires, 76% percent of subjects reported that they were very satisfied or satisfied with the treatment results, and 91% of subjects would likely have the investigational treatment aqain.

The primary and secondary efficacy endpoints were therefore met. The safety endpoints of the clinical study were also met, with subjects experiencing no unexpected adverse events.

In conclusion, the study results demonstrate that the 1064 nm wavelength of the enlighten III laser system, when equipped with a

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Section 5 510(K) Summary

Micro Lens Array handpiece attachment, can safely and effectively be used for the treatment of acne scars.

Summary of Technological Characteristics:	The Cutera enlighten III laser system that was used in the clinical study and is the subject of this submission is identical to the previously cleared enlighten III laser system (K172077). There are no hardware or software changes to the enlighten III laser system associated with this submission. The device design and specifications of the enlighten III laser system with the Micro Lens Array handpiece attachment are also very similar to those of the previously cleared Syneron Candela PicoWay Laser System (K170597) with the Resolve handpiece and the Cynosure PicoSure Workstation (K173199) with the Focus Lens Array handpiece attachment. All of these systems feature a picosecond laser with a fractionated beam, and all have similar mechanisms of action, although beam-splitting mechanisms vary. Beam fractionation is achieved via a micro lens array for the Micro Lens Array handpiece attachment; via a diffractive lens array for the Focus Lens Array handpiece attachment; and via holographic diffractive beam-splitting technology for the Resolve handpiece. The enlighten III laser system with the Micro Lens Array handpiece attachment shares similar key design aspects with its predicate device, including the same or similar laser wavelengths, pulse energy, fluence, spot sizes, and laser types. The minor differences do not raise any new safety or effectiveness questions.
Conclusion:	Clinical testing of the enlighten III laser system with the Micro Lens Array handpiece attachment demonstrated that the device performs as intended with a favorable safety profile. Results in the study were similar to those reported for the PicoWay with the Resolve handpiece, in support of substantial equivalence. The enlighten III laser system with the Micro Lens Array handpiece attachment is substantially equivalent to the predicate devices.

Summary of Technological Characteristics:

The Cutera enlighten III laser system that was used in the clinical study and is the subject of this submission is identical to the previously cleared enlighten III laser system (K172077). There are no hardware or software changes to the enlighten III laser system associated with this submission. The device design and specifications of the enlighten III laser system with the Micro Lens Array handpiece attachment are also very similar to those of the previously cleared Syneron Candela PicoWay Laser System (K170597) with the Resolve handpiece and the Cynosure PicoSure Workstation (K173199) with the Focus Lens Array handpiece attachment. All of these systems feature a picosecond laser with a fractionated beam, and all have similar mechanisms of action, although beam-splitting mechanisms vary. Beam fractionation is achieved via a micro lens array for the Micro Lens Array handpiece attachment; via a diffractive lens array for the Focus Lens Array handpiece attachment; and via holographic diffractive beam-splitting technology for the Resolve handpiece. The enlighten III laser system with the Micro Lens Array handpiece attachment shares similar key design aspects with its predicate device, including the same or similar laser wavelengths, pulse energy, fluence, spot sizes, and laser types. The minor differences do not raise any new safety or effectiveness questions.

Conclusion:

Clinical testing of the enlighten III laser system with the Micro Lens Array handpiece attachment demonstrated that the device performs as intended with a favorable safety profile. Results in the study were similar to those reported for the PicoWay with the Resolve handpiece, in support of substantial equivalence. The enlighten III laser system with the Micro Lens Array handpiece attachment is substantially equivalent to the predicate devices.

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.