(21 days)
The Cynosure SureScan with the CO3 Er: YAG Laser is used for skin resurfacing, and for the incision, excision, ablation or vaporization of soft bodily tissues. Typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT and opthalmology.
The SureScan with the CO3 Er:YAG Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench.
This 510(k) summary for the Cynosure SureScan with the CO3 Er:YAG Laser does not include any acceptance criteria or details of a study proving the device meets said criteria.
The submission explicitly states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
This device was cleared based on its substantial equivalence to a predicate device (Cynosure CO3 Er:YAG Laser) in terms of treatment wavelength, pulse duration, pulse energy, and biological effects, not on specific performance criteria demonstrated through a study.
Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them from 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.