Identifiers
- 510(k) Number
- K171433 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)
The Silk'n Infinity is a light-based over-the-counter hair removal device. It is substantially equivalent to predicate devices and classified under device class 2 with product code OHT.
It is supplied as a reusable system for home use, authorized via FDA 510(k) clearance (K171433) under regulation number 878.4810. The device is intended for general and plastic surgery-related aesthetic applications and is manufactured by Home Skinovations, Ltd.
Frequently asked questions
What is the Silk'n Infinity device used for?
The Silk'n Infinity is intended for general and plastic surgery-related aesthetic applications, specifically as a light-based over-the-counter hair removal device for home use, as stated in its FDA 510(k) clearance documentation.
Is the Silk'n Infinity device reusable or single-use?
The Silk'n Infinity is supplied as a reusable system for home use, meaning it is designed for multiple treatments over time rather than being discarded after a single application.
How was the Silk'n Infinity device cleared for market release?
The Silk'n Infinity received market authorization through an FDA 510(k) clearance (K171433) as a substantially equivalent device to predicate products, classified under device class 2 with product code OHT.
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: Silk'n Infinity Fast - faster permanent hair removal, Home Skinovations Silk'n Infinity Instructions For Use Manual, Silk'n LED Masks | Beauty Devices for Home Use, Silk'n - Home Skinovations Ltd. | LinkedIn
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171433 | Class II | Active |
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Manufacturer
- Manufacturer
- Home Skinovations , Ltd.
Sources (1)
- FDA 510(k) K171433 24 fields · synced Sep 26, 2026