(88 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, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T011C, T016K, are a small over-the-counter 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. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission.
Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001N, Contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone.
Intense Pulsed Light (IPL) System, models: T011C and T016K, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.
Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T023A, T023B, T023D, T023E, T021K, T021A, T011C, T016K, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.
The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.
The provided text is a 510(k) summary for an Intense Pulsed Light (IPL) System. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study acceptance criteria and results for the new device's performance.
Therefore, the document explicitly states: "There was no clinical testing performed."
As such, the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria (including sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) is not available in the provided text.
The document primarily discusses non-clinical tests performed to ensure safety and effectiveness by complying with recognized consensus standards (e.g., electrical safety, EMC, biocompatibility, software verification). The "Discussion of Non-Clinical Tests Performed for Safety and effectiveness" section lists these standards but does not provide specific performance metrics or acceptance criteria related to a clinical outcome of hair removal effectiveness for the subject device.
§ 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.