(112 days)
The O-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
The Q-Rejuvalight Pro Facewear is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. The device uses four types of LEDs for Wrinkles: 605nm, 660nm, and 880nm and two types of LEDs for Acne: 415nm and 630nm. Each mode takes 3 minutes (±3s) for a course of treatment, and the mask will automatically turn off at the end of time.
The Q-Rejuvalight Pro Facewear components include the main device, head strap, eye rest, Latch, User Manual, Storage bag and USB power cord.
The Q-Rejuvalight Pro Facewear is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
The submitted document is a 510(k) summary for the Q-Rejuvalight Pro Facewear. This document primarily focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and conformity to recognized safety and performance standards. It does not contain information about clinical studies with acceptance criteria, reported device performance metrics in relation to those criteria, or details regarding ground truth establishment, sample sizes for test and training sets, expert adjudication, or MRMC studies for this specific device.
The "Test Summary" section lists various safety and performance standards to which the device was evaluated, indicating compliance with these standards for electrical safety, EMC, photobiological safety, and biocompatibility. However, it does not provide acceptance criteria or specific performance results for clinical efficacy of wrinkle reduction or acne treatment.
Therefore, many of the requested details cannot be extracted from this document, as they are not present in a typical 510(k) summary for this type of device. The information provided below is limited to what can be inferred or directly stated from the document regarding technical specifications and safety testing, not clinical effectiveness studies.
Here's the breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria related to efficacy for wrinkle reduction or acne treatment, nor does it provide reported device performance data against such criteria in a clinical context. The "Test Summary" table lists standards for safety and performance (e.g., electrical safety, EMC, photobiological safety, biocompatibility) that the device complies with, but these are not the clinical acceptance criteria you're asking for.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. The document focuses on bench testing and comparison to predicate devices, not clinical trials with test sets.
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 applicable, as no clinical test set with expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This device is a light-emitting therapeutic device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a standalone therapeutic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The ground truth for this medical device clearance is compliance with safety and performance standards and substantial equivalence to legally marketed predicate devices, not clinical efficacy data based on ground truth outcomes for individual patients.
8. The sample size for the training set
Not applicable, as no AI/machine learning training set is mentioned or relevant to this type of device submission.
9. How the ground truth for the training set was established
Not applicable.
Summary based on the provided document:
The Q-Rejuvalight Pro Facewear device has demonstrated compliance with various recognized safety and performance standards through lab bench testing. The 510(k) submission establishes substantial equivalence to predicate devices based on similar intended use, technology (LED-based light therapy), wavelengths, power density (where comparable), treatment time, and environment of use.
The document highlights the following technical characteristics and safety assessments for the Q-Rejuvalight Pro Facewear:
- Intended Use: Treatment of wrinkles and mild to moderate inflammatory acne (OTC device).
- Wavelengths: 605nm, 630nm, 660nm, 880nm (for wrinkles/combination) and 415nm (for acne/combination).
- Power Density:
- Single wavelength: 605nm: 15±5mW/cm², 630nm: 20±5mW/cm², 660nm: 25±5mW/cm², 880nm: 10±5mW/cm², 415nm: 25±5mW/cm²
- Total: 70mW/cm² (wrinkle), 45mW/cm² (acne)
- Treatment Time: 3 minutes per treatment.
- Safety and Performance Standards Compliance (via lab bench testing):
- ANSI AAMI ES60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)
- IEC 60601-1-11 (Requirements for medical electrical equipment in the home healthcare environment)
- IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests)
- IEC 60601-2-57 (Particular requirements for non-laser light source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)
- IEC 62133-2 (Secondary cells and batteries - Safety requirements for lithium systems)
- IEC 62471 (Photobiological safety of lamps and lamp systems)
- Biocompatibility Standards Compliance:
- ISO 10993-5 (Tests for in vitro cytotoxicity)
- ISO 10993-10 (Tests for irritation and skin sensitization)
- ISO 10993-23 (Tests for irritation)
The "Remark" sections (Note 1, 2, 3, 4) in the comparison table explain minor differences between the subject device and predicate devices in terms of power supply, power density details, safety/EMC standards listed, and LED distribution, concluding that these differences "will not raise any safety or effectiveness issues." This implies that the 'acceptance criteria' are met by demonstrating that any differences from the predicate are not significant enough to raise new questions of safety or effectiveness, as demonstrated by compliance with relevant consensus standards.
§ 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.