Cutera enlighten III Laser System

Cutera, Inc.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

4

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K172077
Device name
Cutera enlighten III Laser System
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-07-10
Decision date
2017-10-27
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Pigment treatmentSurgical cutting
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

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)

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

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

Intended Use

The enlighten III laser system is intended for use in surgical and aesthetic applications in the management of benign pigmented lesions and tattoo removal. The 1064 nm wavelength is indicated for treatment of benign pigmented lesions and tattoo removal for dark colored inks on patients with all skin types (Fitzpatrick I-VI). The 532 nm wavelength is indicated for treatment of benign pigmented lesions on Fitzpatrick skin types I-IV and tattoo removal for lighter colored inks on Fitzpatrick skin types I-III. The 670 nm wavelength is indicated for treatment of benign pigmented lesions on Fitzpatrick skin types I-III and tattoo removal for lighter colored inks on 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. The beam of a low-power diode laser is also transmitted through the arm to provide an aiming beam.

Summary parsed at:2026-06-01 06:00:33 UTC

Predicate devices

4

K172077 references 4 predicate/reference devices

Cited as predicate

3

3 submissions cite K172077 as a predicate