# K140727: Cutera Picosecond Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Nov 6, 2014 after 227 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.
47 later devices descend from it; 3 cite it directly.
0 of 304 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
- K153527: PicoWay Laser System (2016), 41 descendants of its own
- K160607: PicoWay Laser System (2016), 34 descendants of its own
- K162454: PicoWay Laser System (2017), 33 descendants of its own
- K170597: PicoWay Laser System (2017), 32 descendants of its own
- K191685: PicoWay Laser System (2019), 20 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. 1064 nm The 1064 nm wavelength of the enlighten laser system is indicated for 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 laser system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

Source page: https://510kreport.com/device/K140727
Methodology: https://510kreport.com/methodology