# K050673: Candela Family of Pulse Dye Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Jun 13, 2005 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904627 (1991). 60 ancestors in all.
133 later devices descend from it; 3 cite it directly.
0 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043251: Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B, Candela Corp. (2005) Summary page 1.
- K033176: Tristar Aesthetic Workstation Laser, Cynosure, Inc. (2004) Summary page 1.
- K032565: Cynosure Photogenica VL, Cynosure, Inc. (2003) Summary page 1.

## Most influential descendants
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own

## Recalls of this device
- Jan 15, 2007 · Not classified · Z-0508-2007: Internal component may overheat causing the possibility of risk of fire or smoke
- Jan 17, 2006 · Not classified · Z-0842-06: Handle fires even when the finger is off the switch

## Indications for use
The Candela Family of Pulse Dye Laser Systems is indicated for the following uses General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented Lesions. Treatment of Inflammatory Acne Vulgaris Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.

Source page: https://510kreport.com/device/K050673
Methodology: https://510kreport.com/methodology