# K170936: Cutera enlighten III Laser System

- Pathway: 510(k) (Special)
- Applicant: Cutera, Inc.
- Decided: Apr 25, 2017 after 26 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: 20 generations back to K943450 (1995). 278 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160488: Cutera enlighten III Laser System, Cutera, Inc. (2016) Summary page 4.

## Most influential descendants
- 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
- K220268: Picosecond Laser System (Model PS10-A and PS10-B) (2022), 1 descendant of its own
- K260017: Picosecond Nd:YAG Laser Systems (Model: HS-298) (2026), 0 descendants 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/K170936
Methodology: https://510kreport.com/methodology