# K990417: Dermacool

- Pathway: 510(k) (Traditional)
- Applicant: Optomed Corp.
- Decided: Apr 14, 1999 after 63 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 K963094 (1996). 4 ancestors in all.
1,062 later devices descend from it; 3 cite it directly.
0 of 1,067 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974381: Candela Gentlelase GL Dermatological Laser, Candela Corp. (1998) Summary page 1.
- K951033: Andela Dynamic Cooling Device, Candela Laser Corp. (1996) Summary page 1.

## Most influential descendants
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL (2002), 1,046 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
- K024093: Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and ND:Yag Laser Systems (2003), 756 descendants of its own
- K033946: Lovely System (2004), 737 descendants of its own

## Indications for use
DermaCool is intended for use with a laser or light source utilized for photo-coagulation of dermatological lesions and is a cooling device indicated for: 1. The reduction of pain, 2. Less discomfort, 3. Cooling of the skin prior, during and after laser or light treatment.

Source page: https://510kreport.com/device/K990417
Methodology: https://510kreport.com/methodology