(99 days)
The Radiancy Facial SkinCare Device is intended for use in dermatology. The Facial SkinCare Device is specifically indicated to treat benign pigmented lesions, including, but not limited to solar lentigines, ephilides (freckles), and mottled pigmentation in patients with Fitzpatrick skin types I-V.
The Radiancy Facial SkinCare Device is a pulsed-light, manually controlled system designed to treat benign pigmented lesions.
This 510(k) summary (K052991) for the Radiancy Facial SkinCare Device does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on:
- Device Identification: Name, manufacturer, contact information.
- Predicate Devices: Identifying previously cleared devices with similar characteristics (Radiancy, Inc. SPR System K033181 and Danish Dermatologic Development A/S Ellipse IPPL ™ K043255).
- Device Description: A pulsed-light, manually controlled system for treating benign pigmented lesions.
- Intended Use/Indications for Use: Specifically for treating benign pigmented lesions (solar lentigines, ephilides (freckles), and mottled pigmentation) in Fitzpatrick skin types I-V.
- Technological Characteristics & Substantial Equivalence: Stating that the device has similar intended use, indications, principles of operation, and technological characteristics to its predicates, and that minor differences do not raise new safety and effectiveness issues, thus demonstrating substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because it is not present in the provided text.
The document is a regulatory submission for premarket clearance based on substantial equivalence to predicate devices, not typically a detailed report on clinical performance or specific testing against predefined 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.