# K993146: Dornier Scanner Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Surgical Products, Inc.
- Decided: Nov 8, 1999 after 49 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981438: Dornier Medilas E, Dornier Surgical Products, Inc. (1998) Summary page 1.
- K946304: Coherent Family of CO2 Surgical Laser Scanner Handpieces, Lumenis, Inc. (1995) Summary page 1.

## Indications for use
The Dornier Scanner handpiece is intended to be used in general and surgical procedures for incision / excision, vaporization, ablation, and coagulation of soft tissue and cartilage. The Dornier Scanner may also be used for skin resurfacing. The Dornier Scanner is for use as an accessory for the Dornier Medilas E Laser (K981438). It is indicated for use in medicine and surgery in the medical specialties as listed in the Indication for Use Statement for the Dornier Medilas E Laser System. No new indications are being requested.

Source page: https://510kreport.com/device/K993146
Methodology: https://510kreport.com/methodology