# K182997: enlighten III Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Dec 12, 2018 after 43 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: 26 generations back to K943450 (1995). 292 ancestors in all.
No later device cites it as a predicate yet.
0 of 293 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172077: Cutera enlighten III Laser System, Cutera, Inc. (2017) Summary page 4.
- K170597: PicoWay Laser System, Syneron Candela Corporation (2017) Summary page 4.
- K173199: PicoSure Workstation, Cynosure, Inc. (2018) Summary page 4.

## 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) • treatment of acne scars on patients with Fitzpatrick skin types II-V when used with the Micro Lens Array handpiece attachment 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-IV • 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 • tattoo removal for lighter colored tattoo inks, including green and blue inks, on patients with Fitzpatrick skin types II-IV

Source page: https://510kreport.com/device/K182997
Methodology: https://510kreport.com/methodology