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

Vbeam Prima is indicated for the following:

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 and 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.

Pediatric Population:
- 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, fine lines and other signs of aging.

Vbeam Prima is indicated for the following: 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 and 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. Pediatric Population: Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas.

The Candela Vbeam Family of Pulsed Dye Lasers includes both the Vbeam Prima and Vbeam Perfecta Laser Systems. The Vbeam Prima Laser System has been previously cleared for both port wine stains, and hemangiomas under K183452. The Vbeam Perfecta (Candela Family of Pulse Laser Systems) has been previously cleared for both port wine stains, and hemangiomas under K050673. This 510(k) Premarket Notification is to expand the indications for use for the Candela Vbeam Family of Pulsed Dye Lasers for the Vbeam Prima Laser System and Vbeam Perfecta to include the pediatric population for treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas for the 595 nm wavelength. There is no new technology being introduced than what has been previously cleared Vbeam Prima Laser System under its predicate K183452 and Vbeam Perfecta under its predicate K050673.