# K133945: Cutera Picosecond Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Aug 11, 2014 after 231 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: 18 generations back to K943450 (1995). 256 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 271 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102954: Cutera Qswitch Laser System, Cutera, Inc. (2011) Summary page 4.
- K073549: Q-Plus T, Quanta System Spa (2008) Summary page 4.
- K121346: Picosure Workstation, Cynosure, Inc. (2012) Summary page 4.

## Most influential descendants
- K160488: Cutera enlighten III Laser System (2016), 13 descendants of its own
- 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

## Indications for use
The enlighten laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 532 nm The 532 nm wavelength of the enlighten laser system is indicated for the treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III. 1064 nm The 1064 nm wavelength of the enlighten laser system is indicated for the treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI).

Source page: https://510kreport.com/device/K133945
Methodology: https://510kreport.com/methodology