# K043251: Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Feb 9, 2005 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: 7 generations back to K904627 (1991). 57 ancestors in all.
136 later devices descend from it; 4 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)
- K001093: Candela SPTL-1B Pulsed Dye Laser, Candela Corp. (2000) Summary page 1.
- K021180: Candela Vbeam Pulsed Dye Laser System, Candela Corp. (2002) Summary page 1.
- K033331: Candela Cbeam Pulse Dye Laser System, Candela Corp. (2004) Summary page 1.
- K033461: Candela Vbeam Pulse Dye Laser System, Candela Corp. (2004) Summary page 1.
- K031488: Cynosure Apogee-TKS II Dermatological Laser, Cynosure, Inc. (2003) Summary page 2.
- K984424: Aura Dye Laser System (Adls), Laserscope (1999) Summary page 2.
- K024206: Aura Isurgical Laser System & Accessories, Laserscope (2003) Summary page 2.
- K024371: Candela Gentle Lase Family of Laser System, Candela Corp. (2003) Summary page 2.

## Most influential descendants
- K050673: Candela Family of Pulse Dye Laser Systems (2005), 133 descendants of its own
- 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

## Indications for use
The Candela Family of Pulse Dye Laser Systems 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. Treatment of Inflammatory Acne Vulgaris Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts. New Indication: Treatment of Benign Epidermal Pigmented Lesions

Source page: https://510kreport.com/device/K043251
Methodology: https://510kreport.com/methodology