# K160488: Cutera enlighten III Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Oct 28, 2016 after 249 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 277 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 291 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133945: Cutera Picosecond Laser System, Cutera, Inc. (2014) Summary page 4.
- K140727: Cutera Picosecond Laser System, Cutera, Inc. (2014) Summary page 4.
- K121346: Picosure Workstation, Cynosure, Inc. (2012) Summary page 4.
- K073549: Q-Plus T, Quanta System Spa (2008) Summary page 4.
- K133254: Revlite Q-Switched ND:Yag Laser System, Cynosure, Inc. (2014) Summary page 4.

## Most influential descendants
- K170936: Cutera enlighten III Laser System (2017), 10 descendants of its own
- K172077: Cutera enlighten III Laser System (2017), 9 descendants of its own
- K173700: PICOPLUS Laser System (2018), 7 descendants of its own
- K200116: PicoSecond Nd: YAG Laser System (2020), 6 descendants of its own
- K240983: Discovery Pico; Discovery Pico Plus; Discovery Pico Derm (2025), 1 descendant of its own

## 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 pigmented lesions on patients with Fitzpatrick skin types I-III.

Source page: https://510kreport.com/device/K160488
Methodology: https://510kreport.com/methodology