(189 days)
The Cylindrically Diffusing Fiber is intended for soft tissue contact and coagulation for all cleared LaserSonics Nd: YAG soft tissue applications.
Cylindrically Diffusing Sterile Disposable Fiber
This document describes a premarket notification for a medical device, a cylindrically diffusing fiber for use with Nd:YAG lasers. However, the provided text does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets acceptance criteria.
The document primarily focuses on:
- Regulatory Information: Company name, contact, device name, classification, and regulatory authority.
- Intended Use: Soft tissue contact and coagulation for specific laser applications.
- Predicate Device Comparison: Stating equivalence to the Dornier ThermaFocus 3600000 Fiber in terms of indications, materials, operation, and construction to justify 510(k) clearance.
Therefore, I cannot answer the questions about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies because this information is not present in 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.