(17 days)
The Quasar Blue Light Therapy System is intended to provide photo therapeutic light to the body. The Quasar Blue Light Therapy System is generally indicated to treat dermatological conditions. The Quasar Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the Quasar Blue Light Therapy System. It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.
However, this document does NOT contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific details regarding standalone or MRMC studies for this device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided 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.