# K984601: Candela Gentlelase II Dermatological Laser

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Feb 4, 1999 after 38 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 K963094 (1996). 7 ancestors in all.
110 later devices descend from it; 6 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981351: Candela Gentlelase GL Dermatological Laser, Candela Corp. (1998) Summary page 1.
- K972767: Candela Gentlelase GL Dermatological Vascular Lesion Laser, Candela Corp. (1997) Summary page 1.
- K974381: Candela Gentlelase GL Dermatological Laser, Candela Corp. (1998) Summary page 1.
- K973354: Sharplan Epitouch Alexandrite Laser System (5000), Sharplan Lasers, Inc. (1997) Summary page 1.
- K971737: Cynosure Photogenica Lpir Dermatological Laser, Cynosure, Inc. (1997) Summary page 1.

## Most influential descendants
- K020412: Depilase Twin Lase Laser System (2002), 106 descendants of its own
- K032218: Adept 1064/532/755 Laser (2003), 104 descendants of its own
- K083207: Ultrawave Iii EX 1320 (2008), 96 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own
- K123168: Q-Plus T+ Ipl Laser System (2012), 40 descendants of its own

## Indications for use
The Candela GentleLase II Dermatology Laser is indicated for the following uses: 1. the photocoagulation of dermatological vascular lesions. 2. the removal of hair. The Candela GentleLase II Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for: 1. the reduction of pain. 2. cooling of skin prior to laser treatment.

Source page: https://510kreport.com/device/K984601
Methodology: https://510kreport.com/methodology