(85 days)
The OptiLITE IX Laser Surgery Accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd: YAG, Argon, Diode, Ho:YAG, and Er:YAG wavelengths for the indications for which the lasers have been cleared.
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I am sorry, but the provided text is a 510(k) clearance letter for "OptiLITE IX Laser Surgery Accessories". It confirms that the device is substantially equivalent to a legally marketed predicate device.
This document does not contain information regarding:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- Data provenance, sample sizes, expert qualifications, or ground truth details.
- Any information related to AI or a multi-reader multi-case (MRMC) comparative effectiveness study.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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.