Sectum
510(k) K202780
Sectum is a Class II device made by Neauvia North America, cleared under FDA 510(k) K202780 on 30 Jul 2021, 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 | NumberK202780 | Date30 Jul 2021 | StatusActive |
Official records
- FDA 510(k) database K202780
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PBX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K202780
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 | |||
|---|---|---|---|---|
| Sectum Body Applicator 300-1301 | 300-1301 | 00850017374140 | — | On the market |
| Sectum Cable Body Applicator 300-1308 | 300-1308 | 00850017374164 | — | On the market |
| Sectum Cable Precise (Face) Applicator 300-1310 | 300-1310 | 00850017374171 | — | On the market |
| Sectum Foot Switch 300-1306 | 300-1306 | 00850017374157 | — | On the market |
| Sectum Precise (Face) Applicator 300-1302 | 300-1302 | 00850017374133 | — | On the market |
| Sectum System 100-1301 | 100-1301 | 00850017374126 | — | On the market |
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- V10 System by VIORA LTD
- Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) by Bios S.R.L.