Sectum System 100-1301
Sectum System 100-1301 is a Class II device made by Neauvia North America, Inc, cleared under FDA 510(k) K202780 on 30 Jul 2021 and listed in FDA GUDID since 27 Sep 2021 (UDI-DI 00850017374126), 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 | Number00850017374126 | Date27 Sep 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202780 | Date30 Jul 2021 | StatusActive |
Official records
- AccessGUDID record 00850017374126
- FDA 510(k) database K202780
Across registries
- FDA 510(k) K202780 decided 30 Jul 2021 Active
- FDA GUDID UDI-DI 00850017374126 listed 27 Sep 2021 Listed
Timeline
- Cleared FDA 510(k) K202780
- Listed FDA GUDID 00850017374126
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sectum System
- Generic name
- Radio-frequency skin/body contouring system
- Model / reference
- 100-1301
- Primary DI / UDI-DI
- 00850017374126
- 510(k) Number
- FDA product code
- GEI, PBX
- GMDN term
- Radio-frequency skin/body contouring system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radio-frequency skin/body contouring system.