(85 days)
The IPL Hair Removal is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the 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 regime.
IPL Hair Removal (Models: SB01, SB01A, SB01C, SN02, SN02, SN03), is an over-the-counter, single-person-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling. reducing hair growth with minimal pain. Model SB01, SB01A, SB01C are powered by lithium battery and can be charged by power adapter, while model SN02 and SN03 are only power adapter. Their IPL emission activation is by finger switch. All models of IPL Hair Removal adopt irreplaceable flash window and are suitable for multiple hair removal areas, including small areas (e.g. underarms, bikini lines) and large areas (e.g. arms, legs). IPL Hair Removal contains a Xenon Arc Flashlamp and a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
The provided document is an FDA 510(k) clearance letter for an IPL Hair Removal device. It does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use, Mode of Action, and Operational Characteristics: The subject device has the same intended use (hair removal and permanent reduction in hair regrowth) and mode of action (Intense Pulsed Light) as the predicate devices.
- Safety Standards Compliance: The device passed tests for biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety and EMC (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83), and eye safety (IEC 62471).
- Software Verification and Validation: Software documentation consistent with a moderate level of concern was submitted, demonstrating that all software requirement specifications are met and hazards mitigated.
Since this document is for an IPL hair removal device using traditional medical device testing for substantial equivalence, it does not contain the detailed information about AI/ML acceptance criteria and studies (like those involving expert readers, ground truth establishment, or MRMC studies) that you requested.
Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance and validation.
§ 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.