# K013748: Candela Sclero Long Pulse Laser (Aka Vbeam)

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Feb 11, 2002 after 90 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: 4 generations back to K904627 (1991). 32 ancestors in all.
699 later devices descend from it; 4 cite it directly.
0 of 732 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013043: Candela Clearbeam Pulsed Dye Laser, Candela Corp. (2001) Summary page 1.
- K011092: Candela SPTL-1E Pulsed Dye Laser, Candela Corp. (2001) Summary page 1.
- K993671: Candela Sclero Long Pulse Dye Laser, Candela Corp. (2000) Summary page 1.
- K943292: Candela SPTL Variable Pulse/Tunable Pulsed Dye Lasers, Candela Laser Corp. (1995) Summary page 1.
- K954934: Candela SPTL Long Pulse/Tunable Pulsed Dye Lase, Candela Laser Corp. (1996) Summary page 1.
- K000811: Nlite System, SLS Model Number A00-1025, Sls Biophile, Ltd. (2000) Summary page 1.

## Most influential descendants
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K021180: Candela Vbeam Pulsed Dye Laser System (2002), 318 descendants of its own
- K033461: Candela Vbeam Pulse Dye Laser System (2004), 316 descendants of its own

## Indications for use
The Candela Vbeam Pulse Dye Laser System is indicated for the following uses in: 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. Treatment of periocular wrinkles. 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/K013748
Methodology: https://510kreport.com/methodology