# K013043: Candela Clearbeam Pulsed Dye Laser

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Oct 11, 2001 after 31 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: 1 generation back to K000811 (2000). 2 ancestors in all.
703 later devices descend from it; 4 cite it directly.
0 of 706 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011092: Candela SPTL-1E Pulsed Dye Laser, Candela Corp. (2001)
- K000811: Nlite System, SLS Model Number A00-1025, Sls Biophile, Ltd. (2000)

## Most influential descendants
- K013748: Candela Sclero Long Pulse Laser (Aka Vbeam) (2002), 699 descendants of its own
- 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

## Indications for use
The Candela Clearbeam 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 lesion, such as warts, scars, striea and psoriasis. Treatment of periocular 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/K013043
Methodology: https://510kreport.com/methodology