K Number

Device Name

Cutera enlighten III Laser System

Manufacturer

Cutera, Inc.

Date Cleared

2016-10-28

(249 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K133945, K140727, K121346, K073549, K133254

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the laser technology, wavelengths, pulse widths, and physical components. There is no mention of AI, ML, image processing for analysis, or any data processing beyond basic parameter selection and clinical study analysis.

Therapeutic

Yes

The device is intended for use in medical specialties for the treatment of benign pigmented lesions and tattoo removal, which are applications aimed at treating or alleviating a condition.

Diagnostic

The enlighten III laser system is intended for surgical and aesthetic applications, specifically for the treatment of benign pigmented lesions and tattoo removal. It does not provide diagnostic information.

SaMD (Software as a Medical Device)

The device description clearly states it is a "multi-wavelength, pulsed laser system" with physical components like a console, touchscreen, footswitch, articulated arm, and handpiece. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the enlighten III laser system is for "surgical and aesthetic applications" in medical specialties like dermatology and surgery. It is used for treating benign pigmented lesions and removing tattoos. These are procedures performed directly on the patient's body.
Device Description: The description details a laser system that delivers a laser beam to the treatment surface via a handpiece. This is a physical intervention on the patient.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are designed for testing samples in a laboratory or clinical setting to diagnose diseases or conditions.

The device is a therapeutic and aesthetic medical device, not a diagnostic one. The performance studies described are evaluating the clinical outcomes of the laser treatment on patients, not the accuracy of a diagnostic test performed on a sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands, body, or face (for benign pigmented lesions)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

An IRB-approved prospective clinical study was conducted to 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 subject-treatment-areas were enrolled in cohort 1; 3 additional subjects with 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

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.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol representing the human form.

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

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

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 – phone
415-715-3568 – fax
brenton@cutera.com
Preparation Date:	October 25, 2016
Device Trade Name:	enlighten III Laser System
Common Name:	Dermatology Laser
Classification Name:	Instrument, Surgical, Powered, laser
79-GEX, 21 CFR 878.4810
Legally Marketed
Predicate 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 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. | | | |
| Indications for Use: | 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 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

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.