# K984349: Dornier Medilas R

- Pathway: 510(k) (Traditional)
- Applicant: Dornier
- Decided: Feb 4, 1999 after 62 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: 5 generations back to K954013 (1996). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981718: Dornier Medilas H, Dornier Surgical Products, Inc. (1998) Summary page 2.
- K981438: Dornier Medilas E, Dornier Surgical Products, Inc. (1998) Summary page 2.
- 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 2.
- K972099: Sharplan Epitouch Ruby Laser System, Sharplan Lasers, Inc. (1997) Summary page 2.

## Indications for use
The Dornier Medilas R Laser is intended to be used in a non-contact technical medical therapy unit, which is indicated for the dermatological application of epilation. The Medilas R is suitable for the following applications: General Surgery, Plastic Surgery, Cosmetology and Dermatology.

Source page: https://510kreport.com/device/K984349
Methodology: https://510kreport.com/methodology