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VITA Multi-Function Head Brush is an Over-The-Counter (OTC) device.

Head Mode: The device is indicated to promote hair growth in male with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic aplopecia who have Ludwig-Savin Classification of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.

Face Mode:
LED therapy function: The device is indicated for the treatment of full face wrinkles and/or mild to moderate inflammatory acne.

The VITA Multi-Function Head Brush is a hand-held device. It consists of a host, a removable treatment head, and a charging cable. The host has a button, indicator lights, and the device's power-on/off, treatment mode switch can be achieved by pressing the button. The removable treatment head has lights row, stainless steel bristles and liquid reservoir (applicable for model TB-2443F/ TB-2442AF), of which the liquid reservoir is used for the hair care after treatment.

The LEDs and low-level lasers in the removable treatment head emit light on the treatment area. In addition, the device is also equipped with a built-in micro motor to generates micro-vibration to relax the facial skin. The device has a head mode and face mode, and the device will automatically shut down after each mode completes treatment within 10 minutes. The device is powered by a built-in rechargeable lithium battery.

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The MEGELIN LED Light Therapy Mask is an Over-the-Counter (OTC) light based device.

• Red light: Treatment of full-face wrinkles.
• Blue light (only suitable model JML1, JML3, JML5, JML6, JML9 Face mask): Treatment of mild to moderate inflammatory acne.

The MEGELIN LED Light Therapy Mask uses blue light (460nm) to treat acne. The MEGELIN LED Light Therapy Mask uses red light (660nm) to irradiate on the facial skin that help reduce wrinkles.

JML1, JML3, JML5, JML6, JML9 are face masks, with the only difference in energy density setting, while JML2, JML4, JML7, JML8, JML10 are neck masks with the only difference in energy density setting.

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The Light Therapy Mask is an over-the-counter device intended for the treatment of full-face wrinkles and mild to moderate inflammatory acne using LED light therapy.

• Red light: Treatment of full-face wrinkles.
• Blue light: Treatment of mild to moderate inflammatory acne.
• Red+Infrared Light: Treatment of full-face wrinkles.
• Mixed light (Red+Blue+Infrared): Treatment of mild to moderate inflammatory acne.

The subject device Light Therapy Mask is a home use wearable LED phototherapy device whose purpose is to produce an even and narrow-band of light for the treatment of aesthetic indications including facial wrinkles and acnes.

The subject device consists of a mask body unit that contains light emitting diodes (LEDs), a controller, straps and USB-C charging cable. And the device is powered by built-in rechargeable lithium battery on the controller.

The LEDs generate 3 kinds of light which include Red light (wavelength 635nm±5nm), Blue light (wavelength 465nm±5nm), Infrared light (wavelength 850nm±5nm). A controller is connect to the mask body unit to control the device, such as turn on/off the device. And the straps used for securing the mask unit to the body part.

The device have vibration function, and user can adjust the vibration intensity. Vibration is for general relaxation purposes.

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The ORA Method LED Gua Sha (Model: GS-04) is an Over-the-Counter (OTC) device indicated to emit energy in red and infrared region of the spectrum for treatment of full-face and decolletage wrinkles.

The ORA Method LED Gua Sha (Model: GS-04) is a hand-held, battery-powered device used for the treatment of full-face and decolletage wrinkles by emitting LED red(630nm) and infrared(830nm) light. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable,charging base, Goggles,storage bag and instruction manual.

The device have two functions:

A) Red and infrared irradiation function:The device emits energy in red and infrared region of the spectrum to reduce wrinkles on the face and decolletage;

B) Vibration and Gua Sha function. The device generates micro-vibration at a frequency of 200 Hz via its built-in micro motor. When used in conjunction with Gua Sha operation, it provides a soothing massage to the skin intended for relaxing the skin.

The recommended treatment time is 10 minutes per area. If you need to continue treatment, simply turn on the device again.

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Jmoon FlexGlow Light Therapy Device is an over the counter device that is intended:

• the Red light and Infrared light is indicated for use in the treatment of full face wrinkles,
• the Blue light and Red light indicated for the treatment of mild to moderate inflammatory acne.

Jmoon FlexGlow Light Therapy Device is an exclusive mirrored tabletop device that contains 464 LEDs. It utilizes LED(light-emitting diode) technology to emit energy in the blue, red and near-infrared spectra for the aim to improve the skin appearance, helping to reduce wrinkles, like fine lines and crow's feet, and treat mild to moderate inflammatory acne. The specific wavelengths of light can act on different skin layers to produce different photobiological effects. The device is to be used at 1 cm distance.The flexible and foldable device unit is designed to be placed on a table for easy exposure to the face and body to ensure consistent light treatment. There are three modes: Acne defense Mode(M01), Anti-wrinkle recovery Mode(M02) and Dual care Mode(M03).

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It is an over-the-counter device that is intended for use in the treatment of wrinkles in the decolletage area.

The subject device LIGHT THERAPY DECOLLETE MASK is a home use wearable LED phototherapy device whose purpose is to produce an even and narrow-band of light for the treatment of cosmetic indications including facial wrinkles and acnes.

The subject device consists of a decollete mask body unit that contains light emitting diodes (LEDs), a controller, straps and USB-C charging cable. And the device is powered by built-in rechargeable lithium battery on the controller.

The LEDs generate 2 kinds of light which include Red light (wavelength 630nm±5nm) and Infrared light (wavelength 850nm±5nm). A controller is connect to the decollete mask body unit to control the device, such as turn on/off the device. And the straps used for securing the decollete mask unit to the body part.

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Red light: Treatment of full-face wrinkles(suitable for model 2344 and model 2457).
Amber light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Red+Infrared Light: Treatment of full-face wrinkles.

The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (630nm±5nm), blue (460nm±5nm), amber (605nm±5nm) and infrared (850nm±10nm) spectrum to irradiate on the face to realize its therapeutic effect. The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color), select energy level and adjust time. To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.

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KALA MINI 2.0 (Model: KALA-04) (Mode 1) 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.

KALA MINI 2.0 (Model: KALA-04) (Mode 2) is an over-the counter device intended for the treatment of full-face wrinkles.

The KALA MINI 2.0 (Model: KALA-04) is a home use light-emitting diode phototherapy device with four proven wavelengths of red light: 630nm, 660nm, and near infrared red light: 830nm, 850nm, the red light (630nm, 660nm) are known to treat the wrinkles and the NIR light (830nm, 850nm) to provide topical heating to elevate tissue temperature for the temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain or muscle spasms and to provide a temporary increase in local blood circulation.

The equipment is a panel that contains LEDs. There are two buttons, one LED display screen on this panel: the button used to control the treatment time and the irradiance of the device; the LED display screen will show the remaining treatment time. Beside the buttons, there are power indicator which will indicate the remaining battery power.

There are fixed straps on the back of the panel, which you can use to hold the panel in your hand. The surfaces patients will contact with hand are constructed of silicone.

The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and be connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The KALA MINI 2.0 (Model: KALA-04) cannot be operated while charging. The cable for connecting with the controller is detachable.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

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The LED Light Therapy Mask (Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.

FCM902, FCM905, FCM906, FCM908:
a.Red light: Treatment of full-face wrinkles.
b.Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
c.Yellow+Infrared light: Treatment of full-face wrinkles.

11-001-RBMASK:
a.Red+Infrared light: Treatment of full-face wrinkles.
b.Blue light: Treatment of mild to moderate inflammatory acne.

FCM910:
a.Red+Infrared light: Treatment of full-face wrinkles.
b.Blue light: Treatment of mild to moderate inflammatory acne.
c.Yellow+Infrared light: Treatment of full-face wrinkles.

The LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) adopts light emitting diodes (LED) in the red (630nm ±5nm) , infrared (880nm±5nm) and blue (415±5nm) spectrum to irradiate on the face to realize its therapeutic effect.

For FCM902, FCM905, FCM906, FCM908 and FCM910, it also contain yellow (590±5nm) spectrum and green (520±5nm) spectrum.

The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.

a. Red light: Treatment of full-face wrinkles.
b. Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
c. Yellow+Infrared light: Treatment of full-face wrinkles.
d. Green Light: light in wavelength 520nm(±5nm). Green light makes users feel like they are outside in a green world, which may make users relax, which has no medical therapeutic effect.
e. Red+Infrared light: Treatment of full-face wrinkles.
f. Blue light: Treatment of mild to moderate inflammatory acne.

The provided FDA 510(k) Clearance Letter concerns an LED Light Therapy Mask for treating wrinkles and mild to moderate inflammatory acne. However, this document is a clearance letter and a 510(k) summary, not a clinical study report. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing.

Therefore, the document does NOT contain the details required to answer many of the specific questions about acceptance criteria and the study that proves the device meets those criteria, particularly those related to clinical performance, human reader studies, or expert ground truth.

The information provided is mostly about device specifications, comparison to predicates, and compliance with non-clinical safety standards (electrical safety, biocompatibility, photobiological safety). It states that "Non-clinical testings have been conducted to verify that the LED Light Therapy Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device."

Based on the provided text, I can only address what is explicitly mentioned or can be reasonably inferred. Most of the questions below would require a separate clinical study report, which is not part of this 510(k) summary.

Acceptance Criteria and Device Performance (Based only on the provided 510(k) Summary):

The acceptance criteria for this device, as inferred from the 510(k) summary, are primarily centered around Substantial Equivalence (SE) to legally marketed predicate devices for the specified indications for use, and compliance with relevant safety and performance standards for an OTC device. The "performance" reported is largely in terms of meeting these technical and safety standards, rather than clinical efficacy metrics from a new human study.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

Based solely on the provided 510(k) summary, the "study" proving the device meets acceptance criteria appears to be a non-clinical testing program focused on product safety and performance standards for substantial equivalence. There is no mention of a human clinical study, an AI component requiring a test set for diagnostic accuracy, or experts establishing ground truth in a clinical context within this document.

Therefore, I cannot provide answers for many of the following questions as the requested information is not present in the provided text.

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

• Not applicable / Not provided. The document describes non-clinical testing of the device itself (electrical, photobiological, biocompatibility, software V&V), not a clinical test set from patients.

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

• Not applicable / Not provided. There is no mention of a test set requiring expert-established ground truth for performance evaluation in this 510(k) summary. This typically applies to AI/CADe devices or clinical efficacy studies, neither of which are detailed here.

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

• Not applicable / Not provided. Since no clinical test set or expert ground truth process is described, an adjudication method is irrelevant.

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, not done / Not applicable. This device is an LED light therapy mask, not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant to this type of device and its 510(k) clearance.

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

• Not applicable. There is no "algorithm only" performance study as this is a physical light therapy device, not a diagnostic algorithm.

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

• Not applicable / Not provided for clinical efficacy. For the non-clinical tests, the "ground truth" would be the specified parameters and limits of the IEC/ISO standards (e.g., maximum allowable leakage current, certified photobiological safety levels, biocompatibility thresholds). There is no mention of a clinical ground truth (e.g., for wrinkle reduction or acne treatment) from a study in this document.

8. The sample size for the training set:

• Not applicable / Not provided. This device is cleared based on substantial equivalence and compliance with non-clinical performance standards. It implies a known or existing mechanism of action (light therapy) rather than a newly developed AI algorithm that requires a training set of data.

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

• Not applicable / Not provided. As no training set for an algorithm is mentioned, the method for establishing its ground truth is also not applicable.

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The FEATHER 01 02 03 04 (Model: 01) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the face.

FEATHER 01 02 03 04 (Models: 01) is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles. The device works by simultaneously emitting 630nm±10nm, 660nm±10nm, 850nm±10nm wavelengths for the treatment of wrinkles. There is only one power/control key on the device, press and hold it for 1.5s to turn on or off the device. Short press the button to adjust the intensity, the white indicator light means the device is running, the flash quickly indicator light means the device is low on power, the slow flashes indicator light means the device is charging.

Based on the provided FDA 510(k) clearance letter for the FEATHER 01 02 03 04 (Model:01) device, here's a breakdown of the acceptance criteria and the study that proves the device meets them.

It's important to note that the provided document is a 510(k) summary, which generally focuses on substantial equivalence to predicate devices rather than detailed clinical trial results for effectiveness when non-clinical tests are deemed sufficient. For this specific device, the submission explicitly states that "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." Therefore, the "study that proves the device meets the acceptance criteria" refers to the non-clinical testing, not a clinical trial demonstrating efficacy.

Acceptance Criteria and Reported Device Performance

Since no clinical efficacy study was conducted for this 510(k) submission, the "acceptance criteria" primarily relate to safety and performance characteristics that demonstrate substantial equivalence to predicate devices. The performance is assessed through non-clinical testing against recognized standards.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Non-Clinical Performance Testing)

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not specified in terms of number of devices tested. For non-clinical performance and safety testing against standards (e.g., IEC 60601 series), usually a sample of devices is tested to demonstrate consistent performance and compliance. The document does not provide specific numbers of units tested.
   • Data Provenance: The testing appears to be conducted by the manufacturer or a third-party testing facility, as indicated by compliance reports against international standards (IEC).
   • Retrospective or Prospective: This type of non-clinical testing is inherently prospective, as it involves newly manufactured devices undergoing specific tests to demonstrate compliance.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable in the typical sense for this submission. Ground truth for non-clinical performance testing is established by compliance with objective, measurable engineering and safety standards (e.g., electrical parameters, light output, battery performance). These are verified by accredited testing labs or qualified in-house engineers, not typically "experts" in the clinical interpretation sense.

3. Adjudication Method for the Test Set:

   • Not applicable. Results are based on objective measurements against predefined thresholds specified in the engineering and safety standards. There's no subjective interpretation requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. The document explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." Therefore, no MRMC study, AI assistance, or human reader improvement data is presented.

5. Standalone (Algorithm Only) Performance:

   • This is not an AI/algorithm-driven diagnostic or treatment device in the context of typical standalone performance studies. It is a light-emitting medical device. The "software" mentioned is for device operation (e.g., power control, intensity adjustment), and its validation ensures the proper functioning of the device, not an algorithm's performance in interpreting data or making clinical decisions.

6. Type of Ground Truth Used:

   • For safety and performance testing, the "ground truth" is defined by the requirements of the international consensus standards (e.g., IEC 60601-1, IEC 62471, IEC 62133-2) and the specifications of the predicate devices. The device is deemed "effective" (in the context of a 510(k) for this type of device) if it meets these safety and performance benchmarks and is substantially equivalent to legally marketed devices for its intended use. There is no pathology or outcomes data presented from a clinical study.

7. Sample Size for the Training Set:

   • Not applicable. This is not a machine learning or AI device that requires a "training set" of data for algorithm development. The testing described is for hardware and embedded software compliance.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for an AI/ML algorithm.

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