Cleane / Cleane Pop
510(k) K111341
Cleane / Cleane Pop is a medical device (FDA Class II; FDA product code OZC, Over The Counter Thermal Treatment For Acne.) made by Medicon Co., Ltd., cleared under FDA 510(k) K111341 on 29 Feb 2012, active as of 10 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 | NumberK111341 | Date29 Feb 2012 | StatusActive |
Official records
- FDA 510(k) database K111341
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OZC
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5740
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K111341
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CLEANE | CLEANE | 08809216198103 | — | On the market |