(63 days)
The Polaris DS is indicated for non invasive hair removal.
The Polaris DS is a device that is used for non invasive hair removal. The Polaris DS treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage to the hair follicle without damaging the surrounding tissues. The Polaris DS is intended for use in dermatology for non invasive hair removal.
The provided document is a 510(k) summary for the Syneron Medical Ltd. Polaris DS device, stating its substantial equivalence to predicate devices for non-invasive hair removal. It does not contain information about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or comparative effectiveness studies.
Therefore, I cannot fulfill your request for the detailed information as the document lacks these specifics. The 510(k) summary focuses on demonstrating substantial equivalence to existing devices rather than presenting the detailed results of a performance study with acceptance criteria.
§ 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.