(162 days)
The device can work in multiple function modes as following with different indication for use:
- The red light is intended to treat periorbital wrinkles.
- The blue light is intended to treat mild to moderate inflammatory acne.
- The Red + IR is intended to treat periorbital wrinkles.
The TheraFace LED device is a lightweight device which uses specified wavelengths of LED light. For LED light irradiation function, the device produces light in the red light region of the spectrum (633±10nm), combination of IR and Red light (830nm±10nm&633 ± 10 nm), or in the blue light region of the spectrum(415±10nm).
The TheraFace LED device consists of a main control unit and its attachment applicators for the LED irradiation ring, which can be controlled by the device control button. The device is powered by one internal lithium rechargeable battery which can be charged by an external batterv charger.
Red light mode: In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit The output is adjustable to one wavelength with a narrow spectral bandwidth in red light. It provides narrow bands of red-light energy and is intended to treat periorbital 633±10nm. wrinkles.
Blue light mode: In blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is adjustable to one wavelength with a narrow spectral bandwidth in 415 ±10nm. It provides narrow bands of blue light energy to facial skin, and is intended to treat mild to moderate inflammatory acne.
Red+ IR mode: When the device is operated in the red combined with infrared light mode, it emits LED light in the RED (633 nm) and IR (830 nm) spectrum on facial skin. It is intended to treat periorbital wrinkles.
This document is a 510(k) summary for the TheraFace LED device, asserting its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, device performance metrics, or study details in the format requested.
Specifically, the document states:
- "There were no clinical studies performed." (Page 9)
- It outlines "Performance Standards Applied" (Page 8-9) which are a series of bench tests for electrical safety, electromagnetic compatibility, and biocompatibility, designed to show the device meets general safety standards, similar to predicate devices. These are not acceptance criteria related to efficacy or clinical performance.
- It mentions "PERFORMANCE TESTING BENCH" (Page 9) including a "Usability Study Report" and "TheraFace LED Light Power Density Test Report," but provides no details on acceptance criteria or results from these reports.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
This document focuses on technical and safety comparisons to predicate devices, not on clinical performance studies.
§ 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.