# K180593: Vbeam Prima Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Syneron-Candela
- Decided: Jun 5, 2018 after 91 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: 9 generations back to K904627 (1991). 62 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050673: Candela Family of Pulse Dye Laser Systems, Candela Corp. (2005) Summary page 4.
- K050779: Cynergy Multiplex Laser, Cynosure, Inc. (2005) Summary page 4.

## Most influential descendants
- K183452: Vbeam Prima Laser System (2019), 1 descendant of its own
- K230990: Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) (2023), 0 descendants of its own

## Indications for use
1,064nm: 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), cafe au lait manules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. 595 nm: 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, psoriasis and the treatment of wrinkles. Treatment of benign epidermal pigmented lesions. Treatment of inflammatory acne vulgaris. 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/K180593
Methodology: https://510kreport.com/methodology