(154 days)
1550 nm. The Fraxel re:store 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
1925 nm: The Fraxel re:store 1925 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
Fraxel re:store (SR 1500) Laser System and Accessories
The provided document is an FDA 510(k) clearance letter for the "Fraxel re:store (SR 1500) Laser System and Accessories." This document does not contain information regarding acceptance criteria or a study that proves the device meets those criteria.
FDA 510(k) clearances are based on demonstrating "substantial equivalence" of a new device to a legally marketed predicate device, not necessarily on specific performance metrics or detailed clinical studies with acceptance criteria in the way a PMA approval might be. The letter confirms the device is cleared for marketing based on equivalence to existing devices for the stated indications for use (dermatological procedures coagulation of soft tissue, skin resurfacing, treatment of dyschromia, cutaneous lesions, periorbital wrinkles, acne scars, and surgical scars).
Therefore, I cannot provide the requested information based on the text provided.
§ 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.