10PL
510(k) K220794
10PL is a medical device (FDA Class II; FDA product code ONF, Powered Light Based Non-Laser Surgical Instrument With Thermal Effect) made by Tentech Co., Ltd., cleared under FDA 510(k) K220794 on 10 Nov 2022, 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 | NumberK220794 | Date10 Nov 2022 | StatusActive |
Official records
- FDA 510(k) database K220794
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ONF
- FDA applicant
- Tentech Co. , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K220794
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 | |||
|---|---|---|---|---|
| 10PL-Body | 10PL-Body | 08809709380411 | — | On the market |
| 10PL-H/P | 10PL-H/P | 08809709380435 | — | On the market |
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