(183 days)
The CoolTouch PRIMA Pulsed Light Therapy System is indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, vascular lesions, rosacea, hemangiomas, leg veins, hair removal, tattoos, pigmented lesions, lentigenes, and mild to moderate inflammatory acne vulgaris.
The CoolTouch PRIMA Pulsed Light Therapy System is a compact, self-contained system that delivers a beam of pulsed light at wavelengths of 300nm to 1400nm, which can be optimized at various wavelength ranges and delivered to the treatment site. The system consists of a control console unit. which houses the power supply, cooling system, cryogen source, and microcontroller, the handpiece, which contains the light source, and the footswitch.
The provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria.
Instead, it's a 510(k) summary for the CoolTouch PRIMA Pulsed Light Therapy System, focusing on its substantial equivalence to predicate devices for various dermatological treatments. The document explicitly states "Nonclinical Performance Data: None. Clinical Performance Data: None."
Therefore, I cannot provide the requested information based on the given text.
§ 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.