# K063074: Candela 3630 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Dec 27, 2006 after 82 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: 8 generations back to K910422 (1992). 61 ancestors in all.
179 later devices descend from it; 5 cite it directly.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033172: Candela Gentleyag Family of Laser Systems, Candela Corp. (2003) Summary page 1.
- 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.
- K034030: Apogee Elite, Cynosure, Inc. (2004) Summary page 1.

## Most influential descendants
- K073534: Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems (2008), 113 descendants of its own
- K081324: Candela Family of Q-Switched Alexandrite Lasers (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K112715: Candela Gentlemax Family of Lasers (2011), 90 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own

## Indications for use
755nm The Candela 3630 Laser System is indicated for the temporary hair reduction. Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick I-IV) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. 1064nm The Candela 3630 Laser System is indicated for the 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/K063074
Methodology: https://510kreport.com/methodology