(179 days)
The New Star Lasers UV-300 Pulsed Light Therapy System is indicated for the treatment of facial, truncal or leg telangiectasia and/or reticular veins, rosasia, port wine stains, hemangiomas, psoriasis, vitiligo, vascular lesions, atopic dermatitis (eczema), seborrheic dermatitis, hair removal, and tattoos. The UV-300 may be used to treat patients with skin types I-VI.
The New Star UV-300 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 (K024259) is a 510(k) premarket notification for the New Star Lasers UV-300 Pulsed Light Therapy System. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical performance studies to prove specific acceptance criteria.
Therefore, the document explicitly states:
- Nonclinical Performance Data: None.
- Clinical Performance Data: None.
Given this, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such studies were not part of this 510(k) submission.
The "conclusion" in the 510(k) summary is that the device is "substantially equivalent to other existing pulsed light systems in commercial distribution for treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, vascular lesions, rosacea, hemangiomas, leg veins, hair removal, and tattoos." This substantial equivalence is based on the device's design, intended use, and technological characteristics being similar to the identified predicate devices, not on new performance data against specific acceptance criteria.
§ 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.