Manufacturer
Cutera, Inc.Cutera enlighten III Laser System
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K160488
- Device name
- Cutera enlighten III Laser System
- Company
- Cutera, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-02-22
- Decision date
- 2016-10-28
- Submission type
- Traditional
- Technology type
- Q-Switched(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatment
- 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-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 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 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-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 enlighten III laser system is indicated for treatment of benign pigmented lesions on patients 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.
Summary parsed at:2026-06-01 06:06:00 UTC
Predicate devices
5Cited as predicate
2Cutera enlighten III Laser System
Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
2 submissions cite K160488 as a predicate
