(87 days)
The Luminance RED Acne Device is intended to enit energy in the spectrum, and is specifically indicated to treat mild to moderate acne.
The Luminance RED Acne Device is a lightweight, handheld device that consists of a body handle and treatment head. The body handle contains 2 LEDs that emit visible blue light (415 nm +/- 10 nm) or visible red light (660 nm +/- 10 nm) through the treatment head to help reduce the appearance of mild to moderate acne. The body consists of a plastic shell which includes a button to turn the device on/off, a button for red visible light, a button for blue visible light, and a digital countdown timer. The Luminance RED Acne Device is powered by a lithium-ion battery.
The provided documents describe the Luminance RED Acne Device, a handheld LED device intended to treat mild to moderate acne. However, the documents do not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The submission is a 510(k) premarket notification, which establishes substantial equivalence to legally marketed predicate devices, rather than proving efficacy through clinical trials with defined acceptance criteria.
The 510(k) summary (Section 5) explicitly states:
- "No clinical testing was conducted as part of this 510(k) submission" (Page 8, Section 5.13).
- The conclusion is based on "nonclinical tests" demonstrating the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate device" (Page 8, Section 5.14).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because it is not present in the provided text.
The closest information available is the comparison to predicate devices for substantial equivalence, which includes characteristics like:
- Indications for Use: Treat mild to moderate acne (same as predicates).
- Energy Type: LED (same as predicates).
- Wavelength: 415 nm (+/-10 nm) and 660 nm (+/-10 nm) (similar to predicates).
- Dose Rate: 4.5 Joules of each wavelength (red and blue), 50 mW/cm² for each (similar to predicates).
- Treatment Regimen: 90 seconds of blue light, then 90 seconds of red light, 2 times per day (similar to predicates).
- Safety Testing: Adherence to IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62471).
- Usability Testing: Yes, per guidance and IEC 62366.
- Biocompatibility Testing: Cytotoxicity, Irritation, Sensitization.
These are design and testing parameters to demonstrate substantial equivalence, not performance acceptance criteria from a clinical study.
§ 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.