(61 days)
The SUPER VELOCE and Accessories are indicated for use in surgical, aesthetic, and cosmetic applications requiring selective photothermalysis (photocoagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
- · Mild to moderate inflammatory and pustular inflammatory acne vulgaris.(420nm filter, 560mm filter) · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) (515nm filter, 560nm filter)
· The treatment of cutaneous lesions including warts, scars and striae; (515nm filter)
· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations; (560nm filter, 590nm filter)
· The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction(590mm filter, 640nm filter, 695nm filter)
· Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, the temporary relief of min associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, and strains, and minor muscular back pain. (800nm filter)
The integral thermo-electric cooler is incoaling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
· Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
· Reduce discomfort during and/or associated with light or laser treatment:
· Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
• Allow the use of higher light or laser fluences for light or laser treatments (such as for hair reatment of vascular or pigmented lesions): and
· Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
Not Found
This document (K241699) is an FDA 510(k) clearance letter for the "Super Veloce" device. It outlines the regulatory classification and general controls applicable to the device, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria.
510(k) clearances typically do not include detailed performance study results or acceptance criteria within the clearance letter itself. Instead, the manufacturer submits this information to the FDA as part of their 510(k) application, and the FDA evaluates it to determine substantial equivalence. The clearance letter only states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval, not on the specific performance study details of the device.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.