Cutera enlighten III Laser System

Cutera, Inc.

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

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

1

Device details

FDA 510(k) registration fields

K number
K170936
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
2017-03-30
Decision date
2017-04-25
Submission type
Special
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 Cutera 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 Cutera 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

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

Intended Use

The 1064 nm wavelength of the Cutera 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 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. The 670 nm wavelength is indicated for treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.

Device Description

The modified Cutera 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 06:00:03 UTC

Predicate devices

4

K170936 references 4 predicate/reference devices

Cited as predicate

1

1 submission cite K170936 as a predicate