# K974536: Photoderm HR System

- Pathway: 510(k) (Traditional)
- Applicant: Esc Medical Systems, Ltd.
- Decided: May 20, 1998 after 169 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: 3 generations back to K910422 (1992). 10 ancestors in all.
1,496 later devices descend from it; 3 cite it directly.
0 of 1,507 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963249: Epilight Hair Removal System, Esc Medical Systems, Ltd. (1997) Summary page 1.
- K950019: Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100, Thermolase Corp. (1995) Summary page 1.
- K962109: SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair Removal, Classy Lady by Mehl of Puerto Rico, Inc. (1997) Summary page 1.
- K963947: Epilaser Normal Mode Ruby Laser, Spectrum Medical Technologies, Inc. (1997) Summary page 1.
- K962446: Sharplan Ruby Laser System, Sharplan Lasers, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL (2002), 1,046 descendants of its own

## Indications for use
The PhotoDerm® HR is used for the removal of unwanted hair.

Source page: https://510kreport.com/device/K974536
Methodology: https://510kreport.com/methodology