(75 days)
BLU TOTALE is an over the counter phototherapy device for use in dermatology for the treatment of mild to moderate acne.
BLU TOTALE is a battery-operated device that uses low power light spectrum at blue LED, at wavelength of 415 ±15nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode (LED) device for the treatment of acne designed for home-use.
The provided text is a 510(k) summary for the BLU TOTALE device (Model: ENEOB852), an over-the-counter phototherapy device for treating mild to moderate acne. This document describes the device, its intended use, and its substantial equivalence to a predicate device (Sapphire, K172555).
However, the document does not contain any information regarding acceptance criteria, performance studies (clinical or otherwise), sample sizes, ground truth establishment, or expert involvement related to demonstrating the device's efficacy for treating acne. The "Non-clinical Testing" section only lists various safety and performance bench tests conducted to conform to international standards (e.g., electrical safety, EMC, biocompatibility, photobiological safety), and does not report on clinical efficacy.
Therefore,Based on the provided text, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because:
1. No clinical efficacy acceptance criteria or corresponding performance claims are present. The document focuses on demonstrating substantial equivalence to a predicate device through shared specifications and conformance to safety and electrical standards. There are no tables of acceptance criteria for treatment efficacy or reported clinical performance metrics in the provided text.
2. No study proving clinical efficacy is described. The "Non-clinical Testing" section details laboratory bench tests for safety (electrical, EMC, photobiological, biocompatibility) and basic device performance (pyrogen, skin temperature, LED wavelength/power density). It does not describe any study (retrospective, prospective, standalone, or MRMC) that evaluates the device's effectiveness in treating acne on human subjects.
Without information on a clinical study or stated performance criteria related to the device's indicated use for acne treatment, it is impossible to answer the specific questions below.
§ 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.