(70 days)
The Shaser HRS2 RX Hair Removal System is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. It is also intended for removal of unwanted hair by using a selective photothermal treatment. The Shaser HRS2 RX Hair Removal System is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types 1 - IV. The Shaser HRS2 RX Hair Removal System is also intended for permanent reduction in unwanted hair. 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 regimen.
Shaser HRS2 RX is an IPL device with a wavelength range of 400-1200 nm. The HRS2 RX is an AC powered, portable device. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
The Shaser HRS2 RX is a light-based hair removal device. The summary provided indicates that no nonclinical nor clinical performance data was submitted for this 510(k) application. Therefore, it is not possible to describe acceptance criteria or a study proving the device meets said criteria based on the provided text.
The submission relies on substantial equivalence to predicate devices (Shaser HRS2 (K120080), Radiancy SpaTouch (K020856), Radiance SkinStation (K051671)) based on having the same intended use, principle of operation, similar pulse energy range, and very similar wavelength range.
Therefore, the requested information cannot be extracted from the provided text as the device's performance was not evaluated through specific studies in 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.