# K021180: Candela Vbeam Pulsed Dye Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Jul 2, 2002 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: 5 generations back to K904627 (1991). 34 ancestors in all.
318 later devices descend from it; 4 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)
- K013748: Candela Sclero Long Pulse Laser (Aka Vbeam), Candela Corp. (2002). Our reading of the summary gave K013784, FDA’s number for Ureteral Stent (Boston Scientific Corp), decided Aug 8, 2002, after this device. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Candela Vbeam Pulsed Dye Laser”.
- K013461: Nlite System,Model A00-1025, Icn Photonics, Ltd. (2002) Summary page 1.

## Most influential descendants
- K033461: Candela Vbeam Pulse Dye Laser System (2004), 316 descendants of its own
- 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

## Indications for use
The Candela Vbeam Pulsed 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 face and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, stria and psoriasis. Periorbital wrinkles and the treatment of wrinkles. 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/K021180
Methodology: https://510kreport.com/methodology