(22 days)
The NLite System is indicated for use in Dermatological and Plastic Sur ery applications and this device is intended for use in the trea ment of periocular wrinkles.
NLite System
I apologize, but the provided text from the FDA 510(k) clearance letter for the "NLite System" does not contain the detailed information required to answer your request about acceptance criteria and study particulars.
The letter is the clearance itself, stating that the device is "substantially equivalent" to predicate devices, but it does not describe the specific performance studies, acceptance criteria, sample sizes, or ground truth methodologies that were submitted to or reviewed by the FDA as part of the premarket notification.
This type of information is typically found within the 510(k) submission document itself, which is often not publicly available in its entirety without a Freedom of Information Act (FOIA) request.
Therefore, I cannot provide the requested table or answer the specific questions about the study from the given 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.