# K230990: Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corporation
- Decided: Jun 1, 2023 after 56 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: 13 generations back to K910422 (1992). 155 ancestors in all.
No later device cites it as a predicate yet.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183452: Vbeam Prima Laser System, Candela Corp. (2019) Summary page 7.
- K050673: Candela Family of Pulse Dye Laser Systems, Candela Corp. (2005) Summary page 7.

## Indications for use
Vbeam Prima is indicated for the following: 595 nm * General Surgery: » Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. * Dermatology/Plastic Surgery: o 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 and the treatment of wrinkles. * Treatment of Benign Epidermal Pigmented Lesions. * Treatment of Inflammatory Acne Vulgaris. * Gynecology: o Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. * Podiatry: o Treatment of benign cutaneous lesions, such as warts. « Pediatric Population o Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas 1064 nm The Vbeam Prima laser system is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus lakes, leg veins, spider veins, and poikiloderma of Civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café-au-lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, peri-ocular and peri-oral wrinkles. Vbeam Perfecta is indicated for the following: 595 nm * General Surgery: « Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. * Dermatology/Plastic Surgery: o 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 and the treatment of wrinkles. » Treatment of Benign Epidermal Pigmented Lesions. » Treatment of Inflammatory Acne Vulgaris. * Gynecology: o Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. « Podiatry: o Treatment of benign cutaneous lesions, such as warts. « Pediatric Population Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas

Source page: https://510kreport.com/device/K230990
Methodology: https://510kreport.com/methodology