# K970757: Fotona Skinscan

- Pathway: 510(k) (Traditional)
- Applicant: Medical Laser Solutions
- Decided: May 9, 1997 after 67 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 K946304 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946304: Coherent Family of CO2 Surgical Laser Scanner Handpieces, Lumenis, Inc. (1995) Summary page 1.

## Most influential descendants
- K021650: Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K970757
Methodology: https://510kreport.com/methodology