# K972767: Candela Gentlelase GL Dermatological Vascular Lesion Laser

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Dec 4, 1997 after 133 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963094 (1996). 1 ancestor in all.
1,179 later devices descend from it; 3 cite it directly.
0 of 1,181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963094: Cynosure Photogenica LP Dermatological Vascular Lesion Laser, Cynosure, Inc. (1996) Summary page 1.
- (no number) Candela Q-Switched Alexandrite Lasers: named in the summary without a submission number

## Most influential descendants
- K974381: Candela Gentlelase GL Dermatological Laser (1998), 1,178 descendants of its own
- K990417: Dermacool (1999), 1,062 descendants of its own
- 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
- K981351: Candela Gentlelase GL Dermatological Laser (1998), 811 descendants of its own

## Recalls of this device
- Nov 6, 2013 · Class II · Z-0348-2014: Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.

## Indications for use
The Candela Gentlelase GL Dermatology Vascular Lesion Laser is used for the photocoagulation of dermatological vascular lesions.

Source page: https://510kreport.com/device/K972767
Methodology: https://510kreport.com/methodology