Feather 01 02 03 04 (Model:01)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251871 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 device is a Light Based Over The Counter Wrinkle Reduction system, as defined in the openFDA data. It is substantially equivalent to a predicate device and received traditional 510(k) clearance.
It is manufactured by Heat IN A Click, LLC and supplied for over-the-counter use. The device is authorized under FDA 510(k) with k-number K251871 and regulation number 878.4810, and is classified as a Class II medical device.
Frequently asked questions
What is the FEATHER 01 02 03 04 (Model:01) device used for?
The FEATHER 01 02 03 04 (Model:01) is a light-based over-the-counter wrinkle reduction system designed for consumer use to reduce the appearance of wrinkles, as defined in the openFDA data and substantially equivalent to a predicate device.
How is the FEATHER 01 02 03 04 (Model:01) supplied and intended for use?
The device is manufactured by Heat IN A Click, LLC and supplied for over-the-counter use, meaning it is available without a prescription for direct consumer purchase and use.
What regulatory clearance does the FEATHER 01 02 03 04 (Model:01) have?
The device received traditional 510(k) clearance from the FDA under k-number K251871 and regulation number 878.4810, and is classified as a Class II medical device based on its substantial equivalence to a predicate.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251871 | Class II | Active |
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Manufacturer
- Manufacturer
- Heat IN A Click, LLC
Sources (1)
- FDA 510(k) K251871 24 fields · synced Sep 23, 2026