LF2 applicator AS100008
LF2 applicator AS100008 is a Class II device made by Venus Concept Inc., cleared under FDA 510(k) K191528 on 6 Sep 2019 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07290016540048), 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 | FDA 510(k)SESE | NumberK191528 | Date6 Sep 2019 | StatusActive |
| United States | GUDID listing | Number07290016540048 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 07290016540048
- FDA 510(k) database K191528
- FDA 510(k) database K143554
Across registries
- FDA 510(k) K191528 decided 6 Sep 2019 Active
- FDA GUDID UDI-DI 07290016540048 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K143554
- Listed FDA GUDID 07290016540048
- Cleared FDA 510(k) K191528
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LF2 applicator
- Generic name
- Radio-frequency skin contouring system applicator, bipolar
- Model / reference
- AS100008
- Primary DI / UDI-DI
- 07290016540048
- FDA product code
- PBX, GEI
- GMDN term
- Radio-frequency skin contouring system applicator, bipolar
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution