Stop X Stop U
by Pollogen Ltd
Stop X Stop U (34300010GR-US) is a Class II device made by Pollogen Ltd, cleared under FDA 510(k) K182774 on 19 Jun 2019 and listed in FDA GUDID since 22 Dec 2020 (UDI-DI 07290018007686), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290018007686 | Date22 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182774 | Date19 Jun 2019 | StatusActive |
Official records
- AccessGUDID record 07290018007686
- FDA 510(k) database K182774
Across registries
- FDA 510(k) K182774 decided 19 Jun 2019 Active
- FDA GUDID UDI-DI 07290018007686 listed 22 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K182774
- Listed FDA GUDID 07290018007686
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stop X
- Generic name
- Multi-modality skin/body contouring system
- Model / Ref / Catalog
- STOP U, 34300010GR-US
- Description
- STOP X MODEL STOP U PACKED GRADIENT RED USA
- Primary DI / UDI-DI
- 07290018007686
- 510(k) Number
- FDA product code
- PAY
- GMDN term
- Multi-modality skin/body contouring system
- Device class
- Class II
- Regulation number
- 878.4420
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).