(27 days)
The SMARTEPIL Laser is indicated for benign vascular lesions and hair removal.
The SMARTEPIL Laser is a pulse Nd:YAG laser utilizing the Nd-YAG crystal as the lasing medium. It is a pulsed laser with a wavelength of 1064nm. Laser activation is either by a finger switch or a footswitch. Overall weight of the laser is 200lbs, and the size is 92cm x 40cm x 80cm (H x W x D). Electrical requirement is 220VAC, 13A, 50-60 Hz, single phase.
The provided 510(k) summary for the SMARTEPIL laser system does not contain information about acceptance criteria or a study proving the device meets them. The document explicitly states "Non-clinical Performance Data: None" and "Clinical Performance Data: None."
This is a pre-amendments 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical or performance data as would be required for more complex or novel devices today.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.
The closest relevant information is contained in the "Conclusion" section of the 510(k) summary:
- Conclusion: "The SMARTEPIL Laser is another safe and effective device for dermatological vascular lesions and hair removal application." This statement serves as the overall conclusion, but it's not supported by specific performance metrics or studies within this document.
§ 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.