(268 days)
B.Light Clear Evo:
- The device is intended for over-the-counter (OTC) use to treat patients with mild to moderate acne vulgaris on the face.
B.Light Restore Evo: — Use of light-based treatment to reduce wrinkles on the face.
The BEMER devices are noninvasive, fully reusable components such as electrodes), and have configurations allowing both patient / home and professional / office use. The subject device is specific to the LED based applications.
Low Level Light Therapy (LLLT) delivered via Light Emitting Diodes (LED) is a nonthermal technology used to modulate cellular activity with specific (nm) of light. Through photo biomodulation, photons are absorbed by chromophores within cells that are being treated. Various beneficial effects of LLLT delivered via light-emitting diodes at relatively low intensities have been reported, especially in indications where stimulation of healing, reduction of pain and inflammation, restoration of function, and skin rejuvenation are required. Light-emitting diode therapy (LED) is safe, nontoxic, and a noninvasive therapy for the treatment of Acne and the reduction of wrinkles and fine lines on the face.
The provided document is a 510(k) Premarket Notification from the FDA for B.Light Clear Evo and B.Light Restore Evo devices. The document mainly focuses on establishing substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. It does not contain information about explicit acceptance criteria or a dedicated clinical study proving the device meets specific performance criteria.
Therefore, many of the requested details, especially those related to clinical studies, will be marked as "Not provided in the document."
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly stated) | Reported Device Performance (from "Comparison of Subject vs. Predicates" and "Non-clinical Testing") |
|---|---|
| B.Light Clear Evo (Acne treatment) | |
| Wavelengths: 465 nm ± 20 nm (Blue) and 645 nm ± 20 nm (Red) | Reported: Blue: 465 nm ± 20 nm; Red: 645 nm ± 20 nm (Matches) |
| Irradiance source: LEDs | Reported: LEDs (Matches) |
| Power intensity (Red): 0.76 mW/cm² | Reported: Red: 0.76 mW/cm² (Matches) |
| Power intensity (Blue): 1.20 mW/cm² | Reported: Blue: 1.20 mW/cm² (Matches) |
| Treatment dose: 1 J/cm² per treatment | Reported: 1 J/cm² per treatment (Matches) |
| Treatment time: 8 minutes per day, 30 days | Reported: 8 minutes per day, 30 days (Matches) |
| Total treatment time: 240 minutes | Reported: 240 minutes (Matches) |
| B.Light Restore Evo (Wrinkle reduction) | |
| Wavelengths: 860 nm ± 20 nm (IR) and 645 nm ± 20 nm (Red) | Reported: IR: 860 nm ± 20 nm; Red: 645 nm ± 20 nm (Matches) |
| Irradiance source: LEDs | Reported: LEDs (Matches) |
| Power intensity (Red): 0.56 mW/cm² | Reported: Red: 0.56 mW/cm² (Matches) |
| Power intensity (IR): 1.40 mW/cm² | Reported: IR: 1.40 mW/cm² (Matches) |
| Treatment dose: 1 J/cm² per treatment | Reported: 1 J/cm² per treatment (Matches) |
| Treatment time: 8 minutes per day, 30 days | Reported: 8 minutes per day, 30 days (Matches) |
| Total treatment time: 240 minutes | Reported: 240 minutes (Matches) |
| General Safety and Performance | |
| Safety and EMC standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-57 | Reported: Compliance with these standards (Matches) |
| Biocompatibility standards: ISO 10993-1 | Reported: Compliance with ISO 10993-1 (Matches) |
| Software/Firmware/Microprocessor controlled | Reported: Yes (Matches, indicating successful functionality testing) |
| Home healthcare environment | Reported: Testing covered home healthcare (Matches, indicating suitability for intended use environment) |
| Non laser-light source equipment | Reported: Testing covered non laser-light source equipment (Matches) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided in the document. The document primarily relies on non-clinical performance testing and comparison to predicate devices, not clinical trials with patient test sets.
- Data Provenance: Not applicable, as no clinical trial data for the subject device is presented. The document mentions non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided in the document. This information would typically come from a clinical study, which is not detailed here for the subject device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the document, as no clinical study with a test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done or reported in this document. The devices are light therapy devices and do not involve "readers" or "AI assistance" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The devices are light therapy applicators, not diagnostic algorithms. The performance discussed is the physical characteristics and safety of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical testing, the "ground truth" refers to established engineering standards, specifications, and regulatory requirements (e.g., IEC 60601 series for safety and EMC, ISO 10993-1 for biocompatibility). The document indicates that the device met these standards. No clinical ground truth (like pathology or outcomes data) for the subject device's performance in treating acne or wrinkles is presented in this document.
8. The sample size for the training set
- Not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. The document describes a physical medical device, not an AI/ML algorithm.
§ 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.