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The Red Light is intended to treat full face wrinkles.
The Blue Light is intended to treat mild to moderate inflammatory acne.
The Yellow Light is intended to treat wrinkles.

The GLAM LED light therapy mask is a home use wearable light emitting diode 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 of the face. The outer shell of the mask is manufactured from Polyethylene terephthalate (PET). The inner shell is a clear Polycarbonate (PC). The Light emitting diodes are mounted behind the clear Polycarbonate. The LEDs generate the light. The ear hooks are made of Acrylonitrile butadiene styrene (ABS) and the silicone goggle protect the eyes from LED lights. Unfold the ear hooks and place the mask on your face, the mask will automatically activate the light therapy mode. The LEDs produce blue, red and yellow light in the visible spectrum (Blue:415nm +/- 10nm, Yellow: 590nm +/-10nm, Red: 625nm +/-10nm.). The device works by emitting the specified wavelengths to treat full face of wrinkles or to treat mild to moderate inflammatory acne. Press the touch switch on the right ear hook twice to select the light therapy mode you want to use. Each mode operates in a 15-minute cycle. After 15 minutes, the device automatically deactivates the light mode and enters the standby mode.

This FDA 510(k) clearance letter for the GLAM LED Facial Mask (TB-2386F) does not include any information regarding clinical testing, acceptance criteria for device performance related to efficacy (e.g., wrinkle reduction or acne treatment), or studies comparing the device's performance against such criteria.

The letter focuses on the substantial equivalence based on:

• Technological Comparison: Comparing light wavelengths, power density, and treatment time to predicates.
• Safety Standards Compliance: Verification through non-clinical tests (electrical safety, EMC, biocompatibility, photobiological safety, software verification).

Therefore, I cannot provide details on the specific acceptance criteria for efficacy or a study proving the device meets those criteria from the provided document. The 510(k) summary explicitly states: "No animal or clinical study is included in this submission."

However, if we were to hypothesize what acceptance criteria and a study might look like for a device with these indications, and then illustrate what would be missing from this document:

Hypothetical Acceptance Criteria and Performance Study (Not Found in Provided Document):

Since the provided document explicitly states no clinical study was included, the following tables and sections represent what would typically be expected for a device claiming therapeutic efficacy, but none of this information is present in the provided 510(k) clearance letter.

Hypothetical Acceptance Criteria and Reported Device Performance (If Clinical Data Existed)

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The LED Facial Mask is an over-the-counter (OTC) device intended for the following uses:

For Red Mode(s): The device emits energy in the red spectrum and is intended for the treatment of full-face wrinkles.

For Red + NIR Mode: The device emits energy in the red and infrared spectrum and is intended for the treatment of full-face wrinkles.

For Blue Mode: The device emits light in the blue region of the spectrum and is specifically indicated for the treatment of mild to moderate acne on the face.

For NIR Mode: The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

The LED Facial Mask is a device used for treatment of full-face wrinkles, mild to moderate acne on the face, and providing topical heating. LEDs housed inside the device emit light onto the face. These LEDs generate blue, red, and infrared wavelengths.

This product is composed of the main device, controller, fastening straps, storage bag, blindfold, and charging cable.

This FDA 510(k) clearance letter pertains to an LED Facial Mask, which is categorized as a Class II medical device. The information provided outlines the manufacturing, intended use, and comparison to predicate devices, but it does not contain the specific performance data one would expect for a study proving the device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to already cleared predicate devices based on technological characteristics and intended use. The "Performance Data" section lists various recognized consensus standards to which the device was tested (e.g., electrical safety, electromagnetic compatibility, usability, biological evaluation), rather than clinical study results establishing efficacy.

Therefore, I cannot create the detailed table of acceptance criteria and reported device performance, nor can I answer questions about sample size, ground truth establishment, expert adjudication, or MRMC studies, as this information is not present in the provided FDA clearance letter.

It explicitly states: "Clinical/animal testing was not performed for the proposed device as part of the submission." This confirms the absence of efficacy studies that would typically define acceptance criteria for performance outcomes.

The acceptance criteria for this device, as implied by the FDA 510(k) process for a Class II device, are largely related to safety, performance against engineering standards, and substantial equivalence to legally marketed predicate devices. The clearance is based on the premise that if the new device is sufficiently similar to existing cleared devices in terms of its technology and intended use, and meets relevant safety standards, it does not require new clinical efficacy data.

Here's a breakdown of what can be inferred from the document regarding acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:

Inferred Acceptance Criteria and Device "Performance" (Non-Clinical)

Since no clinical efficacy studies were performed, the "acceptance criteria" are not related to a specific clinical outcome (e.g., X% reduction in wrinkles, Y% clearance of acne). Instead, they relate to safety, electrical performance, and biocompatibility, as demonstrated through testing against consensus standards.

Study Details (Based on the Provided Document)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of clinical data for efficacy. The "test set" here refers to the device itself being tested against engineering and safety standards. There is no patient sample size.
   • Data Provenance: The tests conducted are in vitro (bench testing) and in silico (software analysis) or conducted on the physical device itself, not on human subjects. Therefore, there's no country of origin for patient data, nor is it retrospective or prospective clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The "ground truth" for the engineering and safety tests is defined by the consensus standards themselves (e.g., a certain voltage tolerance, a specific emission limit). The "experts" would be the engineers and technicians performing the tests and verifying compliance with the standards, not clinical experts establishing ground truth for medical conditions.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This concept pertains to clinical studies where human interpretation of medical data needs to be harmonized. For engineering tests, results are typically objective measurements against a standard.

4. 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. This type of study is for AI/CADe devices and involves human readers reviewing cases. This device is an LED facial mask, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This applies to AI/CADe devices.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this clearance is adherence to recognized consensus standards for safety, electrical performance, photobiological safety, and biocompatibility, as well as demonstrated technical similarity and intended use alignment with predicate devices. There is no clinical ground truth (e.g., biopsy results, clinician's diagnosis) involved in this substantial equivalence determination.

7. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" for this device.

8. How the ground truth for the training set was established:

   • Not applicable.

In summary, the provided FDA 510(k) clearance document for the LED Facial Mask demonstrates that the device was cleared based on its substantial equivalence to existing devices and its adherence to a series of non-clinical safety and performance standards. No clinical efficacy studies were conducted or required for this particular clearance, as explicitly stated in the document.

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LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

The LED Facial Mask is an over-the-counter, facemask-shaped design light emitting diode (LED) device that emits light energy in the red, blue, and amber spectrum for the treatment of wrinkles or mild to moderate inflammatory acne on the face. The device consists of a mask body unit, controller, and AC adapter. The mask body unit contains light emitting diodes (LEDs) that emit visible red light (650nm+/-5nm), amber light (605nm+/-5nm), or blue light (465nm+/-5nm) to help reduce the appearance of wrinkles or mild to moderate acne. A controller is connected to the mask body unit to control the device, such as turn on/off the device, switch LED color output. An AC adapter is used to power the device. To use the device, user should place the mask body unit over the face and use the controller to operate. The device will automatically turn off after each treatment.

The LED Facial Mask includes MZ-01, NEWKEY-01, and SP-FM-01 models. Their intended use, performance, structure design, and operation are identical, with the difference being the product appearance, but these differences do not affect or change the intended use of the device.

The provided text is a 510(k) summary for an LED Facial Mask, a medical device for over-the-counter use in treating wrinkles and mild to moderate acne. However, it does not contain information about studies that prove the device meets acceptance criteria related to its clinical efficacy.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through technical specifications, safety data (biocompatibility, electrical safety, eye safety), and software verification and validation. There's no mention of clinical trials or performance studies evaluating the device's effectiveness in treating wrinkles or acne in accordance with specific acceptance criteria beyond general safety and design similarity to other cleared devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving the device meets them for its intended clinical effects because such information is not present in the provided text. The document primarily details technical and safety compliance, not clinical performance metrics.

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LED Facial Mask is an over the counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The Red and Infrared light combination mode is intented for the treatment of full-face wrinkles. The blue light is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.

LED Facial Mask (Model: AST-804, AST-804A, AST-804B, AST-805, AST-805A, AST-805B)

The provided text is an FDA 510(k) clearance letter for an LED Facial Mask. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

The letter only states that the device is "substantially equivalent" to a legally marketed predicate device for the following indications for use:

• Red light mode: Treatment of periorbital wrinkles.
• Red and Infrared light combination mode: Treatment of full-face wrinkles.
• Blue light: Treatment of mild to moderate inflammatory acne.
• Target population: Adults only.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in the 510(k) submission itself, not in the clearance letter.

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