# K980160: Epilaser I Upgrade Kit

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Mar 10, 1998 after 53 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 K950019 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963947: Epilaser Normal Mode Ruby Laser, Spectrum Medical Technologies, Inc. (1997) Summary page 5.

## Indications for use
The Epilaser® I is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

Source page: https://510kreport.com/device/K980160
Methodology: https://510kreport.com/methodology