(95 days)
Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, 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.
Not Found
This document is a 510(k) clearance letter from the FDA for the Philips Lumea IPL device. It does not contain any information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria.
The letter primarily covers:
- The FDA's review and determination of substantial equivalence for the Philips Lumea IPL.
- Regulatory information and requirements for marketing the device.
- The device's indications for use: "removal of unwanted hair for a single user" and "permanent reduction in hair regrowth, 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 device is for Over-The-Counter Use.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets them, as the provided text doesn't concern an AI/software device or its performance study.
§ 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.