# K991935: Epilight Hair Removal System, Photoderm HR System

- Pathway: 510(k) (Traditional)
- Applicant: Esc Medical Systems, Ltd.
- Decided: Jan 27, 2000 after 232 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: 4 generations back to K910422 (1992). 16 ancestors in all.
1,492 later devices descend from it; 10 cite it directly.
0 of 1,509 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.
- K974536: Photoderm HR System, Esc Medical Systems, Ltd. (1998) Summary page 1.
- K980517: Epilaser Normal Mode Ruby Laser, Palomar Medical Products, Inc. (1998) Summary page 1.
- K982980: Lightsheer Long Pulse Ruby Laser, Palomar Medical Products, Inc. (1999) Summary page 1.
- K982940: Lightsheer Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems (2003), 856 descendants of its own
- K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems (2003), 756 descendants of its own

## Indications for use
EpiLight® is used for the removal of unwanted hair. EpiLight®is also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime. PhotoDerm® HR is used for the removal of unwanted hair. PhotoDerm® HR is also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

Source page: https://510kreport.com/device/K991935
Methodology: https://510kreport.com/methodology