STOP U (Packed Black USA), STOP U (Packed White USA)
FDA 510(k)Class II (US FDA 510(k))
by Pollogen Ltd
Identifiers
- 510(k) Number
- K182774 FDA 510(k)
- FDA Product Code
- PAY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4420 FDA 510(k)
- Regulation Number
- 878.4420 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The STOP U is an Over-the-Counter Radiofrequency Coagulation Device for Wrinkle Reduction, classified as a Class II medical device. It employs radiofrequency energy to non-invasively treat mild to moderate facial wrinkles by generating controlled heat in the dermis and subcutaneous layers, promoting tissue remodeling and collagen stimulation.
The device is supplied as a packaged system including an applicator unit, power supply, and preparation gel. It is intended for single-use and requires no sterilization. The STOP U is regulated under FDA 510(k) clearance (K182774) and falls under the product code PAY, with regulatory classification under 878.4420. No MRI safety information or reusable components are specified in the data.
Frequently asked questions
What is the primary purpose of the STOP U device, and how does it work to address facial wrinkles?
The STOP U is an over-the-counter radiofrequency coagulation device designed for non-invasive wrinkle reduction. It uses controlled radiofrequency energy to generate heat in the dermis and subcutaneous layers of the skin, stimulating collagen production and promoting tissue remodeling to improve mild to moderate facial wrinkles.
Is the STOP U device intended for repeated use, or is it meant to be used once and then discarded?
The STOP U is explicitly designed for single-use only. Since it is not sterilized and contains no reusable components, it should not be reused after a single treatment session.
What components are included in the STOP U packaged system, and do I need to purchase any additional supplies?
The STOP U is supplied as a complete packaged system, including an applicator unit, power supply, and preparation gel. No additional supplies are required beyond what is included in the box.
How should the STOP U device be stored, and are there any special handling instructions?
While the device data does not specify storage conditions in detail, as a single-use medical device, it should be stored in a clean, dry place away from direct sunlight and extreme temperatures. Always follow manufacturer guidelines for optimal performance and safety.
What regulatory pathway was followed for the STOP U, and which medical specialty is it associated with?
The STOP U was cleared through the FDA’s 510(k) process (K182774) under the product code PAY, with a regulatory classification of 878.4420. It is associated with the medical specialty of General Plastic Surgery, as indicated by the advisory committee review.
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: STOP U (Packed Black USA), STOP U (Packed White USA) (K182774) — FDA ..., Stop U (Packed Black Usa); Stop U (Packed White Usa) (K140255) — Fda ..., K182774 FDA 510(k) - STOP U (Packed Black USA) | Pollogen, Ltd., STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA) - beudamed.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182774 | Class II | Active |
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Manufacturer
- Manufacturer
- Pollogen Ltd
- FDA Applicant
- Pollogen, Ltd.
Sources (1)
- FDA 510(k) K182774 24 fields · synced Sep 19, 2026