# K980560: Fotona Skinplus Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Mar 27, 1998 after 42 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: 2 generations back to K953585 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962902: Fotona Skinlight Laser System, Medical Laser Solutions (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K970934: CB Erbium/2.94(TM) ER:Yag Laser, Continuum Biomedical, Inc. (1997). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Fotona SkinPlus Er:YAG surgical laser system is indicated for the cutting, ablation, vaponization, coagulation ot soft issue, and for skin resurfacing.

Source page: https://510kreport.com/device/K980560
Methodology: https://510kreport.com/methodology