# K963947: Epilaser Normal Mode Ruby Laser

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical Technologies, Inc.
- Decided: Mar 5, 1997 after 154 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 K950019 (1995). 2 ancestors in all.
1,546 later devices descend from it; 7 cite it directly.
0 of 1,549 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955612: RD-1200H Normal Mode Ruby Laser System, Spectrum Medical Technologies, 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.

## Most influential descendants
- K973324: Starlight Pulsed Diode Array Laser System (1997), 1,535 descendants of its own
- K982940: Lightsheer Pulsed Diode Array Laser System (1999), 1,526 descendants of its own
- K980517: Epilaser Normal Mode Ruby Laser (1998), 1,509 descendants of its own
- K974536: Photoderm HR System (1998), 1,496 descendants of its own
- K980420: Lightsheer (1998), 1,494 descendants of its own

## Indications for use
The Epilaser™ Normal Mode Ruby Laser is intended to effect hair removal of patients with skin types 1 - 4 through selective photothermolysis of hair follicles in dermatology and plastic surgery. This results in a prolonged growth delay.

Source page: https://510kreport.com/device/K963947
Methodology: https://510kreport.com/methodology