# K980420: Lightsheer

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: May 4, 1998 after 90 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.
1,494 later devices descend from it; 1 cites it directly.
0 of 1,498 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 2.

## Most influential descendants
- K982980: Lightsheer Long Pulse Ruby Laser (1999), 1,493 descendants of its own
- K991935: Epilight Hair Removal System, Photoderm HR System (2000), 1,492 descendants of its own
- K023954: Altus Medical Coolglide Laser Systems and Accessories (2003), 1,117 descendants of its own
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL (2002), 1,046 descendants of its own
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller (2002), 1,018 descendants of its own

## Indications for use
The LightSheer™ is intended to effect haix removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles.

Source page: https://510kreport.com/device/K980420
Methodology: https://510kreport.com/methodology