Vbeam Prima Laser System

Syneron-Candela

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K180593
Device name
Vbeam Prima Laser System
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2018-03-06
Decision date
2018-06-05
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Vascular treatmentPigment treatmentSkin resurfacing
Primary application
Vascular treatment
Classification source
AI classified

Indications for Use

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. 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.

Intended Use

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. 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.

Device Description

The Vbeam Prima Laser system is designed as a transportable device that delivers laser energy at wavelengths of 595 nm (pulse-dye) or 1064 nm (Nd: YAG). The device is comprised of a main console, power supply, controlled electronics, firmware, software, cooling system, and handpieces. The handpiece offers a set of distance gauges available in the following spot ranges: 3-7 mm, 7-11 mm, 11-15 mm, and 3 X 10 mm. The user selects treatment settings, such as fluence, number of pulses, and spot size selection via a color touch screen. The handpiece incorporates a Dynamic Cooling Device (DCD) into its handpiece that is designed to cool the skin surface during treatment, which consists of an electrically controlled spray nozzle, cryogen reservoir canister and an electronic control circuitry. The Vbeam Prima Laser System also offers an optional EverCool Delivery System Handpiece for skin cooling during treatment.

Summary parsed at:2026-06-01 05:57:17 UTC

Predicate devices

2

K180593 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K180593 as a predicate