# K111144: Candela Gentlelase Family of Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Jul 18, 2011 after 87 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: 6 generations back to K963094 (1996). 17 ancestors in all.
91 later devices descend from it; 1 cites it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024371: Candela Gentle Lase Family of Laser System, Candela Corp. (2003) Summary page 1.
- K024335: Candela Gentlelase Family of Laser Systems, Candela Corp. (2003) Summary page 1.
- K024260: Candela Gentlelase Family of Laser Systems, Candela Corp. (2003) Summary page 1.
- K994260: Candela Gentlelase GL Dermatological Laser, Candela Corp. (2000) Summary page 1.
- K981351: Candela Gentlelase GL Dermatological Laser, Candela Corp. (1998) Summary page 1.
- K974381: 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.

## Most influential descendants
- K112715: Candela Gentlemax Family of Lasers (2011), 90 descendants of its own
- K132185: Family of Coolglide Aesthetic Lasers (2013), 36 descendants of its own
- K153671: Family of CoolGlide Aesthetic Lasers (2016), 32 descendants of its own
- K170626: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece (2017), 24 descendants of its own
- K133319: ET Lightsheer 1060, High Speed Lightsheer 1060 (2014), 24 descendants of its own

## Indications for use
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Source page: https://510kreport.com/device/K111144
Methodology: https://510kreport.com/methodology