Facial & Body Beauty Device (INIA-BD001 +13 more)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252553 FDA 510(k)
- FDA Product Code
- NFO FDA 510(k)
- Models / Variants
- INIA-BD001 FDA 510(k)INIA-BD002 FDA 510(k)INIA-BD003 FDA 510(k)INIA-BD004 FDA 510(k)F2C15 FDA 510(k)F3222 Pro FDA 510(k)F5516 FDA 510(k)F3606 FDA 510(k)F2210 Pro FDA 510(k)F5808 FDA 510(k)INIA-ED001 FDA 510(k)INIA-ED002 FDA 510(k)INIA-BLD001 FDA 510(k)E1507 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Facial & Body Beauty Device is a hand-held device for over-the-counter aesthetic purposes. It is a transcutaneous electrical stimulator intended for aesthetic use, as indicated by its device name and classification.
The device is supplied as a reusable hand-held unit and is regulated under FDA 510(k) clearance K252553. It is classified as a Class II device with product code NFO and regulation number 882.5890, and its use is associated with neurology specialty per the advisory committee description.
Frequently asked questions
What is the Facial & Body Beauty Device intended for?
The Facial & Body Beauty Device is a hand-held transcutaneous electrical stimulator intended for over-the-counter aesthetic purposes, as indicated by its device name and classification under product code NFO.
Is the Facial & Body Beauty Device reusable or single-use?
The device is supplied as a reusable hand-held unit, meaning it is designed for multiple uses over time rather than being discarded after a single application.
How is the Facial & Body Beauty Device regulated?
The device is regulated under FDA 510(k) clearance K252553, classified as a Class II device with product code NFO and regulation number 882.5890, and its use is associated with the neurology specialty per the advisory committee description.
What models are included in the Facial & Body Beauty Device product line?
The product line includes the following models: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, and E1507.
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: Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA ..., Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003 ..., Facial & Body Beauty Device | Medical Device Navigator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252553 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Jianchao Intelligent Technology Co., Ltd.
Sources (1)
- FDA 510(k) K252553 24 fields · synced Sep 27, 2026