# K033461: Candela Vbeam Pulse Dye Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Jan 16, 2004 after 78 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 K904627 (1991). 36 ancestors in all.
316 later devices descend from it; 5 cite it directly.
0 of 353 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021180: Candela Vbeam Pulsed Dye Laser System, Candela Corp. (2002) Summary page 1.
- K024189: Nlite System, Model#: A00-1025/A00-1033, Icn Photonics, Ltd. (2003) Summary page 1.

## Most influential descendants
- K053047: Fraxel SR Laser System (2006), 205 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K063038: Fraxel Iii SR Laser System and Accessories (2007), 195 descendants of its own
- K071051: Fraxel Iii SR Laser System and Accessories (2007), 194 descendants of its own
- K080915: Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories (2008), 187 descendants of its own

## Indications for use
The Candela Vbeam Pulse Dye Laser is indicated for the following uses in: General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, 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. New indication: Treatment of Inflammatory Acne Vulgaris Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology. Podiatry: Treatment of benign cutaneous lesion, such as warts.

Source page: https://510kreport.com/device/K033461
Methodology: https://510kreport.com/methodology