Identifiers
- 510(k) Number
- K150077 FDA 510(k)
- FDA Product Code
- NFO 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)
The SonicLift ST261 is a transcutaneous electrical stimulator designed for aesthetic purposes. It functions as a facial toning device that delivers electrical stimulation to the skin.
This device is authorized under FDA 510(k) clearance K150077. It is a battery-operated personal care product that includes a charging stand for power management.
Frequently asked questions
What is the primary purpose of the SonicLift ST261?
The SonicLift ST261 is a transcutaneous electrical stimulator intended for aesthetic purposes. It functions as a facial toning device that delivers electrical stimulation directly to the skin.
How is the SonicLift ST261 powered?
This device is a battery-operated personal care product. It includes a dedicated charging stand to facilitate power management and ensure the device is ready for use.
Is the SonicLift ST261 authorized for use?
Yes, the SonicLift ST261 is authorized under FDA 510(k) clearance K150077. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices.
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: Pretika SonicLift ST261 Instructions For Use Manual, Pretika SonicLift ST261 Manuals | ManualsLib, SonicLift: FDA Clearance & Evidence Check | SkinCarisma, Pretika SonicLift ST261 - User Manual, Pretika ST261 SonicLift GUDID Device - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150077 | Class II | Active |
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Manufacturer
- Manufacturer
- Pretika Corporation
Sources (1)
- FDA 510(k) K150077 24 fields · synced Sep 23, 2026