Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240264 FDA 510(k)
- FDA Product Code
- OHT 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)
This device is a Light-Based Over-the-Counter Hair Removal Device, classified under FDA product code OHT. It employs light technology to reduce unwanted hair growth on the skin, targeting areas such as the face, legs, arms, and underarms. The device is designed for home use and operates without the need for professional medical intervention, providing a non-invasive alternative to traditional hair removal methods like shaving or waxing. Its mechanism relies on controlled light energy to inhibit hair follicle activity, promoting gradual hair reduction over time.
The device is supplied as a reusable, non-sterile consumer product intended for personal use in a home setting. It requires no special storage conditions but should be kept clean and dry when not in use. The device has received FDA 510(k) clearance under the Substantial Equivalence determination, affirming its compliance with regulatory standards for light-based hair removal systems. Multiple model variants (T10A through T19A) are authorized, each adhering to the same classification and regulatory framework.
Frequently asked questions
What is the Home Use Hair Removal Device (T10A-T19A) used for?
This device uses controlled light energy to inhibit hair follicle activity, providing a non-invasive alternative to traditional hair removal methods like shaving or waxing. It is designed for home use to reduce unwanted hair growth on areas such as the face, legs, arms, and underarms. The mechanism promotes gradual hair reduction over time, making it suitable for long-term management of hair growth.
Is the Home Use Hair Removal Device reusable or single-use?
The device is explicitly designed as a reusable, non-sterile consumer product. It is intended for personal use in a home setting and does not require disposal after a single use. Proper cleaning and maintenance are necessary to ensure safe and effective operation over multiple uses.
What storage conditions are required for the Home Use Hair Removal Device?
No special storage conditions are required for this device. However, it should be kept clean and dry when not in use to maintain its functionality and hygiene. Avoid exposing it to moisture or extreme temperatures, as this could affect performance or safety.
Are there different models available, and how do they differ?
Yes, multiple model variants are available, including T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, and T19A. While each model adheres to the same regulatory framework and classification, differences may exist in design, features, or intended use—such as targeted treatment areas or power settings. Always refer to the manufacturer’s instructions for model-specific guidance.
How is the regulatory status of this device determined?
The device has received FDA 510(k) clearance under the Substantial Equivalence determination, confirming compliance with regulatory standards for light-based hair removal systems. This classification falls under FDA product code OHT, and the device is authorized for home use without requiring professional medical intervention. The clearance process ensures it meets safety and effectiveness requirements for its intended use.
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: Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D, T11A ..., Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D, T11A ..., K240264 FDA 510(k) - Home Use Hair Removal Device (Model(s):T10A
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240264 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mlay Intelligent Technology Co., Ltd.
- FDA Applicant
- Shenzhen Mlay Intelligent Technology Co., , Ltd.
Sources (1)
- FDA 510(k) K240264 24 fields · synced Oct 5, 2026