(263 days)
The LED Light Therapy Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask is an over-the-counter device intended to emit energy in the red and Near Infrared spectrum and is intended for the use in the treatment of full-face wrinkles.
The LED Light Therapy Mask is a home use wearable light emitting diode (LED) phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face. The system consists of a Face mask and a controller. The Face mask contains the light emitting diodes (LEDs). The LEDs generate the light. The mask is worn on the face and is held in place by adjustable head strap. The LEDs produce blue, red and near infra-red (NIR) light in the visible spectrum (Blue: 415nm +/- 10nm, Red: 630nm +/- 10nm, NIR 830nm +/-10nm.). The controller allows the user to select one of two treatment modes (acne or wrinkles) and switches the LEDs ON/OFF, controlling power to the mask. The modes can be selected by short pressing the Power/mode button. The controller contains a countdown timer and counts down from 10 minutes. The user may stop the treatment during the 10 minutes by long pressing Power/mode button. The controller contains a rechargeable Lithium-ion polymer battery. The controller uses a Power indicator to show the user the battery power level during working status and the charge status during charging. The Power adapter and power cable are used to charge the Lithium battery. The power cable is also used to connect the controller and face mask during working status. The LED Light Therapy Mask cannot be operated while charging. The LED Light Therapy Mask includes optional heating pads for the lower eyelids, providing localized thermal comfort within a temperature range of 38℃~41℃. The heating function is controlled via the controller and does not interfere with the treatment of acne or wrinkles.
The provided document is an FDA 510(k) clearance letter and summary for the LED Light Therapy Mask (RT01). It does not contain information about a specific study proving the device meets acceptance criteria, but rather a summary of non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Here's an breakdown of the information requested based only on the provided text, with clear indications where the information is not available:
Acceptance Criteria and Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative format for specific performance metrics of the device itself (e.g., efficacy rates for acne reduction or wrinkle improvement). Instead, the performance is demonstrated through compliance with various safety and electrical standards, and a statement of "substantial equivalence" to a predicate device based on identical technical specifications and indications for use.
Below is a table summarizing the non-clinical tests performed that verify the device meets requirements, inferred as "acceptance criteria" in this context. The "reported device performance" is the statement that the device met these requirements.
| Acceptance Criteria Category (Non-Clinical Test) | Reported Device Performance |
|---|---|
| Product service life | Met requirements |
| Software validation | Met requirements |
| Electromagnetic compatibility and electrical safety | Met requirements (compliance with IEC standards) |
| Performance test | Met requirements |
| Biocompatibility Test | Met requirements (compliance with ISO and USP standards) |
| Usability Testing | Met requirements (compliance with IEC standards) |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
- Therefore, there is no sample size for an clinical "test set" and no data provenance information available for such a test. The performance was established through non-clinical bench testing and comparison to a predicate device.
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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/Not provided. As no clinical test data was used, no experts were needed to establish ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No clinical test set.
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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/Not provided. This device is a light therapy mask, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This device is a light therapy mask, not an algorithm. Its performance is inherent to its physical operation, not an output of an algorithm in the context of diagnostic performance. However, "Software verification and validation testing" was conducted, and the software was classified as "moderate concern," to ensure its safe operation, not diagnostic accuracy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests was established by compliance with recognized international standards (e.g., IEC for electrical safety, ISO for biocompatibility). For substantial equivalence, the "ground truth" was the technical specifications and performance of the legally marketed predicate device (MZ Skin LightMAX Supercharged LED Mask 2.0, K213184).
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The sample size for the training set:
- Not applicable/Not provided. As no clinical test data was used and the device is not an AI/algorithm that requires a training set in this context.
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How the ground truth for the training set was established:
- Not applicable/Not provided. No training set was used for clinical performance evaluation.
§ 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.