Identifiers
- 510(k) Number
- K161892 FDA 510(k)
- FDA Product Code
- NUV 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 Slimming Treatment Device is a massager that uses vacuum, light-induced heating, and is classified under product code NUV. It is substantially equivalent to a predicate device and received FDA 510(k) clearance on March 2, 2017, under regulation number 878.4810 for general and plastic surgery applications.
The device is manufactured by Beijing Honkon Technologies Co., Ltd. and is supplied as a non-sterile, reusable device intended for use in clinical or aesthetic settings. It requires no special storage conditions beyond standard handling and is not MRI safe unless explicitly stated; no sterility, single-use, or MRI safety claims are present in the provided data.
Frequently asked questions
What is the Slimming Treatment Device used for?
The Slimming Treatment Device is a massager that uses vacuum and light-induced heating, intended for general and plastic surgery applications as indicated by its FDA 510(k) clearance and product code NUV classification.
Is the Slimming Treatment Device sterile or single-use?
The device is supplied as non-sterile and reusable, with no claims of sterility or single-use status in the provided data, meaning it must be cleaned and reprocessed between uses according to facility protocols.
How is the Slimming Treatment Device supplied and stored?
It is supplied as a non-sterile, reusable device requiring no special storage conditions beyond standard handling, and is not MRI safe unless explicitly stated, which is not indicated in the device data.
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: Diode Laser & IPL Hair Removal,Beauty Equipment Supplier -HONKON Laser, Slimming Treatment Device (K161892) — FDA 510(k) | Innolitics, HONKON Slimming VI Body Shaping Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161892 | Class II | Active |
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Manufacturer
- Manufacturer
- Beijing Honkon Technologies Co., Ltd
- FDA Applicant
- Beijing Honkon Technologies Co., Ltd.
Sources (1)
- FDA 510(k) K161892 24 fields · synced Sep 22, 2026