# K033172: Candela Gentleyag Family of Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Oct 30, 2003 after 30 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: 7 generations back to K910422 (1992). 55 ancestors in all.
654 later devices descend from it; 10 cite it directly.
0 of 710 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010104: Candela Long Pulse ND:Yag, Candela Corp. (2001)
- K022923: Candela Gentle Yag Laser System, Candela Corp. (2003) Summary page 2.
- K022951: Candela Gentle Yag Laser System, Variable Pulse Yag, Candela Corp. (2003) Summary page 2.
- K023193: Candela Gentle Yag Laser System, Candela Corp. (2002) Summary page 2.
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration), Laserscope (2002) Summary page 1.
- K003765: Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration), Laserscope (2001) Summary page 1.
- K003147: Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration), Laserscope (2000)
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 1.
- K010834: Lyra Series Surgical Laser System & Accessories, Laserscope (2001) Summary page 1.

## Most influential descendants
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K040617: Reliant Laser System II (2004), 316 descendants of its own
- K042319: Reliant Laser II System and Accessories (2005), 284 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K061652: Palomar LUX1540 Handpiece (2007), 259 descendants of its own

## Indications for use
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicted on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions. such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea,Venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

Source page: https://510kreport.com/device/K033172
Methodology: https://510kreport.com/methodology