(12 days)
Flash N Go is an over the counter device intended for the removal of unwanted hair. Flash N Go is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
The Flash N Go hair removal system is a pulsed light system composed of a base unit and hand held applicator.
The provided text describes the 510(k) summary for the Silk'n Flash N Go hair removal device. However, it does not contain the specific details required to answer your request regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, or specific study results.
The document only states:
- "Clinical data was collected in a prospective multisite clinical study."
- The intended use includes "permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime."
- The device complies with "21CRF § 1040.10 & 1040.11" (performance standards for light-emitting products).
The requested information (acceptance criteria table, sample sizes, ground truth details, MRMC study, standalone performance) is not available in the provided text. This type of detailed performance data and study design would typically be found in the full 510(k) submission or an associated clinical study report, which is not included here.
Therefore, I cannot fulfill your request with the given 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.