(63 days)
Indications for use for the Pure Laser diode hair removal system with a 810nm applicator include:
- · Hair removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- · Treatment of Pseudo folliculitis Barbae (PFB)
- · Use on all skin types (Fitzpatrick I-VI)
The PURE Laser system is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength laser diode built-in a HP, with a 10x10mm spot size and ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI).
The device is sold with an electroconductive gel with prior FDA clearance – EndyGel (K161715).
This document (K222369) is a 510(k) summary for the PURE Laser, a device intended for hair removal. It does not contain information about the performance of an AI/ML device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Elysion-pro (K193367)) based on technological characteristics and adherence to safety and performance standards for laser equipment. It explicitly states that "No clinical studies were conducted as part of this submission."
§ 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.