(224 days)
The SellaS® is intended for use in : Dermatological procedures requiring the coagulation of soft tissue;
Not Found
I am sorry, but based on the provided text, I cannot provide the requested information. The document is a clearance letter from the FDA for a device named "SellaS®," indicating it is substantially equivalent to a legally marketed predicate device.
The letter does not include any information about:
- Acceptance criteria: It does not define specific performance metrics the device needs to meet.
- A study proving device performance: It does not describe any studies, their methodologies, results, or the metrics used to evaluate the device.
- Sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document is purely a regulatory letter granting market clearance based on substantial equivalence, not a performance report or a summary of a clinical study.
§ 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.