# K962446: Sharplan Ruby Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: Mar 7, 1997 after 256 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 K910422 (1992). 6 ancestors in all.
1,497 later devices descend from it; 1 cites it directly.
0 of 1,504 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961279: Sharplan Lasers, Inc. Ruby Laser System, Sharplan Lasers, Inc. (1996) Summary page 1.
- K950019: Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100, Thermolase Corp. (1995) Summary page 1.
- K892514: Ahrs Epilator 629, American Hair Removal System Co. (1990) Summary page 1.
- K955612: RD-1200H Normal Mode Ruby Laser System, Spectrum Medical Technologies, Inc. (1996). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- 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
- K023954: Altus Medical Coolglide Laser Systems and Accessories (2003), 1,117 descendants of its own

## Indications for use
It is intended for use in dermatology for the removal of unwanted dark body hair.

Source page: https://510kreport.com/device/K962446
Methodology: https://510kreport.com/methodology