EmFace or Evoke AG608082A
EmFace or Evoke AG608082A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K191855 on 29 Oct 2019 and listed in FDA GUDID since 27 Oct 2022 (UDI-DI 07290016633504), 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 | Number07290016633504 | Date27 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191855 | Date29 Oct 2019 | StatusActive |
Official records
- AccessGUDID record 07290016633504
- FDA 510(k) database K191855
Across registries
- FDA 510(k) K191855 decided 29 Oct 2019 Active
- FDA GUDID UDI-DI 07290016633504 listed 27 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K191855
- Listed FDA GUDID 07290016633504
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EmFace or Evoke
- Generic name
- Radio-frequency skin surface treatment/fat liquefaction system control unit
- Model / Ref / Catalog
- AG608082A
- Primary DI / UDI-DI
- 07290016633504
- 510(k) Number
- FDA product code
- PBX
- GMDN term
- Radio-frequency skin surface treatment/fat liquefaction system control unit
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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