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510(k) Data Aggregation
(168 days)
CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)
For MK-90C:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90C) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris of the face and use in the treatment of full-face wrinkles.
For MK-90M:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90M) is an over the counter device intended for the use in the treatment of full face wrinkles.
For MK66RB-F:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK66RB-F) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris.
For MK-90N:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90N) is an over the counter device, is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles.
The CurentBody™LED 4 in 1 Zone Facial Mapping Mask is a home wearable light-emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of mild to moderate acne vulgaris of the face. The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by adjustable Velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface, Both surfaces are constructed of silicone The CurentBody™LED 4 in 1 Zone Facial Mapping Mask has 4 models, MK-90C, MK-90M, MK66RB-F and MK-90N.The controller contains a rechargeable lithium battery. The user charges the controller by connecting the charging cable with an adapter (AC100-240V, 50Hz/60Hz 5V 2A).The LED Light Therapy Mask cannot be operated while charging.
This document describes the FDA's decision to clear the CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask based on its substantial equivalence to previously marketed devices. As such, it does not include a detailed study proving the device meets acceptance criteria specific to a new AI/imaging algorithm. Instead, it relies on demonstrating that the new device is as safe and effective as existing, cleared devices through non-clinical testing and comparison.
Therefore, many of the specific questions about AI/imaging algorithm acceptance criteria, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this 510(k) submission, which is for a light therapy device.
However, I can extract information related to the device's technical specifications and how its performance and safety were evaluated against predicate devices.
Here's a breakdown of the available information, addressing the relevant points and noting where information is not applicable due to the nature of the device and submission type:
1. Table of acceptance criteria and reported device performance:
The document doesn't present "acceptance criteria" in the traditional sense of a specified performance threshold (e.g., >X% accuracy). Instead, the acceptance criteria for this 510(k) submission are implicitly met by demonstrating substantial equivalence to predicate devices in areas of safety and effectiveness. The "reported device performance" is largely framed as compliance with recognized standards and similarity to the predicate devices.
| Feature/Test | Acceptance Criteria (Implied by Predicate Equivalence & Standards Compliance) | Reported Device Performance |
|---|---|---|
| Product Code | Same as predicate devices (OHS, OLP) | OHS, OLP |
| Regulation Number | Same as predicate devices (21 CFR 878.4810) | 21 CFR 878.4810 |
| FDA Device Classification | Same as predicate devices (Class II) | Class II |
| Use | Over The Counter | Over The Counter |
| Indications for Use | Similar to predicate devices: treatment of mild to moderate acne vulgaris of the face (MK-90C, MK66RB-F), full-face wrinkles (MK-90C, MK-90M), periorbital wrinkles (MK-90N), and generally dermatological conditions. | MK-90C: Treat mild to moderate acne vulgaris of the face and full-face wrinkles. |
| MK-90M: Full face wrinkles. | ||
| MK66RB-F: Treat mild to moderate acne vulgaris. | ||
| MK-90N: Generally dermatological conditions and specifically periorbital wrinkles. | ||
| Noted as "Similar" to predicates. | ||
| Intended Location of Use | Face | Face |
| Energy Type | Light Emitting Diodes | Light Emitting Diodes |
| Wavelengths | Within or covered by the variance range of predicate devices. Device passed IEC 60601-2-57. | MK-90C: Red + Infrared (633nm+830nm), Blue + Red (415nm+633nm), Yellow + Infrared (590nm+830nm). |
| MK-90M: Red + Infrared (633nm+830nm). | ||
| MK66RB-F: Red + Blue (633nm+415nm). | ||
| MK-90N: Yellow + Infrared (590nm+830nm). | ||
| Noted as "Similar" and covered by predicate's ±10nm variance. | ||
| Power Density | Power density should not raise new safety concerns compared to predicates. Lower effective irradiance compared to secondary predicate is acceptable. | 415nm: 25±5mW/cm²; 633nm: 20±5mW/cm²; 590nm: 15±5mW/cm²; 830nm: 10±5mW/cm². |
| Noted as "Different" but acceptable as proposed device's effective irradiance is less than secondary predicate's, indicating no increased safety concerns. | ||
| LED Distribution | Uniform distribution | Uniform distribution |
| Treatment Time | Similar to predicate devices (e.g., 10 minutes) | 10 minutes (for some modes/models, other predicate times vary, but considered "Same" or acceptable). |
| Treatment Protocol | Similar to predicate devices (e.g., 5x weekly for 6 weeks for wrinkles, 4x weekly for 6 weeks for acne). | Wrinkles: 5 x weekly, 6 weeks; Acne: 4 x weekly, 6 weeks. |
| Software Controlled | Device uses a timer and software to control treatment duration. | Device uses a timer and software to control treatment duration. |
| Biocompatibility | No Cytotoxicity, No Skin Sensitization, No Irritation. Compliance with ISO 10993-5, 10993-10, 10993-23. | No Cytotoxicity, No evidence of skin sensitization, No irritation. Compliant with ISO 10993-5, 10993-10, 10993-23. |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-1-11 (Home Healthcare Environment). | Comply with IEC 60601-1, IEC 60601-1-11. |
| Electromagnetic Compatibility (EMC) | Comply with IEC 60601-1-2. | Comply with IEC 60601-1-2. |
| Photobiological Safety | Comply with IEC 62471. Compliance with IEC 60601-2-57 (Particular requirements for non-laser light source equipment). | Comply with IEC 62471, IEC 60601-2-57. |
| Software Verification & Validation (V&V) | Software V&V conducted as per FDA guidance for "basic level concern" software; no "minor injury" from malfunction/latent design flaw expected. | Software V&V testing conducted and documentation provided as recommended by FDA guidance. Software classified as "basic level concern." |
| Light Output Test | Output of light consistent with specifications. | Validated that the output of light is as stated in the specifications. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This submission relies on substantial equivalence through non-clinical performance and safety testing against recognized standards, and comparison to predicate devices, rather than a clinical trial with a "test set" of patients.
- Data Provenance: Not applicable in the context of patient data. The provenance of the testing data would be from the manufacturer's internal labs or contracted testing facilities for engineering, electrical, and biocompatibility tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is not an AI/imaging algorithm that requires ground truth established by experts for a test set. Its performance relies on physical specifications, light output, electrical safety, and biocompatibility, as measured against engineering standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no "test set" of patient cases requiring adjudication by experts.
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 is a light therapy device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not have a standalone algorithm for diagnostic or interpretative performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. "Ground truth" in the context of clinical outcomes or imaging interpretation is not relevant here. The "ground truth" for this device's safety and effectiveness is established through adherence to recognized international and electrical safety standards (e.g., IEC 60601 series, IEC 62471, ISO 10993 series) and demonstration that its physical and functional characteristics are "substantially equivalent" to already cleared predicate devices.
8. The sample size for the training set:
- Not applicable. The device is not based on a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. The device is not based on a machine learning model that requires ground truth for a training set.
Summary of Study Type:
The "study" that proves this device meets the "acceptance criteria" (defined as substantial equivalence to predicates and compliance with safety standards) is a non-clinical performance and safety testing program, as outlined in section 5.1 and 5.2 (Non-Clinical Test, Biocompatibility Test, Light output, and Software verification and validation). No clinical studies were deemed necessary for this 510(k) submission, as stated in section 5.5. The performance is assessed through technical specifications and their adherence to established safety and performance norms for similar devices.
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