# K961279: Sharplan Lasers, Inc. Ruby Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: Jun 18, 1996 after 76 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: 1 generation back to K910422 (1992). 2 ancestors in all.
1,498 later devices descend from it; 1 cites it directly.
0 of 1,501 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910422: Model RD-1200 Ruby Laser System, Spectrum Medical Technologies, Inc. (1992) Summary page 1.
- K924647: DLR-1 Derma-Lase Ruby Laser/DLR-1/Derma-Lase Syst, Derma-Lase Co. (1993) Summary page 1.

## Most influential descendants
- K962446: Sharplan Ruby Laser System (1997), 1,497 descendants of its own
- K974536: Photoderm HR System (1998), 1,496 descendants of its own
- K991935: Epilight Hair Removal System, Photoderm HR System (2000), 1,492 descendants of its own
- K013366: Prolite Pulsed Light System for the Removal of Unwanted Hair (2002), 1,129 descendants of its own
- K022568: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair (2002), 1,127 descendants of its own

## Indications for use
It is intended for use in dermatology for photothermolysis, for the specific indications {in adults (18 years or older)} to remove blue-black tattoos, or to remove or lighten benign epidermal pigmented lesions.

Source page: https://510kreport.com/device/K961279
Methodology: https://510kreport.com/methodology