# K962902: Fotona Skinlight Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Laser Solutions
- Decided: Jan 10, 1997 after 169 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: 1 generation back to K953585 (1996). 1 ancestor in all.
63 later devices descend from it; 4 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953585: Schwartz Electro-Optices, Inc. Trilase 2100/20 Holmium Laser, Schwartz Electro-Optics, Inc. (1996) Summary page 1.

## Most influential descendants
- K971648: Sharplan Erbium: Yag Laser (4020) (1997), 58 descendants of its own
- K981438: Dornier Medilas E (1998), 56 descendants of its own
- K050317: Burane XL (2005), 53 descendants of its own
- K052806: Burane (2005), 52 descendants of its own
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own

## Indications for use
The laser is intended to be used for cutting, vaporizing, and coagulating soft tissue.

Source page: https://510kreport.com/device/K962902
Methodology: https://510kreport.com/methodology