(213 days)
The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.
Intense Pulsed Light (IPL) System, model: T012C
I am sorry, but based on the provided FDA 510(k) clearance letters (K212881) for the "Intense Pulsed Light (IPL) System," there is no information available regarding the acceptance criteria, the study that proves the device meets those criteria, or any details about a clinical study.
The documents provided are administrative notifications from the FDA concerning the substantial equivalence determination for an IPL device. They primarily cover:
- Administrative Correction: A notice updating contact information.
- Substantial Equivalence Determination: A letter stating that the device is substantially equivalent to legally marketed predicate devices.
- Regulatory Information: Details about regulations, product codes, a reminder about compliance with general controls, and information on post-market reporting.
- Indications for Use: Stating the device is an over-the-counter device intended for the removal of unwanted body hair.
None of these documents contain the kind of detailed clinical study information (acceptance criteria, performance data, sample sizes, expert qualifications, ground truth establishment, MRMC studies, etc.) that you are asking for.
To get the information you are requesting, you would typically need to refer to the device's 510(k) summary or the full 510(k) submission, neither of which is provided in the input text. FDA 510(k) summaries, when available, often contain a brief overview of the performance data submitted for clearance, if performance data was required and submitted. However, for a Class II device like this IPL system, clearance is often based on demonstrating substantial equivalence to a predicate device, which may or may not require new clinical performance data if the technological characteristics and intended use are sufficiently similar to the predicate.
§ 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.