CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250966 FDA 510(k)
- FDA Product Code
- OHS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) is a wearable, flexible silicone device for home-use wrinkle reduction. It emits red (633nm) and near-infrared (830nm) light via LEDs to treat facial skin. This device is intended for the treatment of full-face wrinkles.
The CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) is supplied as a non-sterile, reusable device. It is FDA 510(k) cleared with product code OHS and is classified as a Class II medical device for light-based over-the-counter wrinkle reduction. The device is intended for home use and is not MRI safe.
Frequently asked questions
What is the CurrentBody Skin LED Light Therapy Mask Series 2 used for?
The CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) is a wearable, flexible silicone device designed for home-use wrinkle reduction. It emits red (633nm) and near-infrared (830nm) light via LEDs to treat facial skin, specifically intended for the treatment of full-face wrinkles.
How is the CurrentBody Skin LED Light Therapy Mask supplied and is it reusable?
The CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) is supplied as a non-sterile, reusable device. It is designed for multiple uses and is not intended for single-use disposal after application.
What is the regulatory status of the CurrentBody Skin LED Light Therapy Mask?
The device is FDA 510(k) cleared with product code OHS and is classified as a Class II medical device for light-based over-the-counter wrinkle reduction. It is intended for home use and is not MRI safe.
Are there different sizes or models available for the CurrentBody Skin LED Light Therapy Mask?
The CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) is available as a single model. The device is designed to fit the full face for comprehensive wrinkle treatment, though specific sizing details are not provided in the available information.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Gesundheit & Beauty Tech Experten | CurrentBody DE, CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) (K250966 ..., CurrentBody LED Mask | Medical Device Navigator, CurrentBody Skin™ LED Light Therapy Mask Series 2… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250966 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Kaiyan Medical Equipment Co, . Ltd
- FDA Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
Sources (1)
- FDA 510(k) K250966 24 fields · synced Sep 22, 2026