Pollogen STOP U Model UXV Device
by Pollogen Ltd
510(k) K220322
Pollogen STOP U Model UXV Device is a medical device (FDA Class II; FDA product code PAY, Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction) made by Pollogen Ltd, cleared under FDA 510(k) K220322 on 4 May 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220322 | Date4 May 2023 | StatusActive |
Official records
- FDA 510(k) database K220322
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PAY
- FDA applicant
- Pollogen, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4420
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).