# K152737: Lite Touch

- Pathway: 510(k) (Traditional)
- Applicant: Focus Medical, LLC
- Decided: Jun 29, 2016 after 280 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: 13 generations back to K943450 (1995). 152 ancestors in all.
No later device cites it as a predicate yet.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150140: MCL 31 Dermablate, Asclepion Laser Technologies GmbH (2015) Summary page 4.

## Indications for use
Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: • Dermatology • Cosmetic surgery • Plastic and general surgery • Oral surgery • Gynecology • Otorhinolaryngology • Podiatry

Source page: https://510kreport.com/device/K152737
Methodology: https://510kreport.com/methodology