(105 days)
Diode Laser Hair Removal System (RD-SLD600) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The proposed device, Diode Laser Hair Removal System (RD-SLD600) is a professional platform, it is intended for the removal of unwanted hair and to effect stable, long-term hair reduction on all skin types (Fitzpatrick skin type I-VI). The complete system consists of its console, module and a footswitch. The module is pressed against the patient's skin and a light pulse is delivered when the emitted button or the footswitch are activated. The crystal contact surface is cooled by the RD-SLD600's cooling system. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system's microcontroller through and LCD touch-screen.
The provided text is a 510(k) Summary for a Diode Laser Hair Removal System (RD-SLD600). It asserts substantial equivalence to predicate devices based on non-clinical testing. Crucially, no clinical studies were performed for this device as part of the submission. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria through clinical performance.
The document states:
- "Clinical testing was not performed for the subject device as part of the submission." (page 8)
- The conclusion is based on non-clinical tests (Electrical Safety and Electromagnetic Compatibility, and Biocompatibility) which determined the device to be "safe and effective for its intended use, and performs as well or better than the predicate devices" (page 8).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study was explicitly not conducted according to 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.