# K972099: Sharplan Epitouch Ruby Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: Aug 27, 1997 after 84 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 K910422 (1992). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962109: SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair Removal, Classy Lady by Mehl of Puerto Rico, Inc. (1997) Summary page 1.

## Most influential descendants
- K984349: Dornier Medilas R (1999), 0 descendants of its own

## Indications for use
The Sharplan Ruby Laser System, with its fiber delivery system, is intended for use in dermatology for the removal of unwanted body hair.

Source page: https://510kreport.com/device/K972099
Methodology: https://510kreport.com/methodology