Morpheus8V Applicator AG609931A
Morpheus8V Applicator AG609931A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K180189 on 1 Jun 2018 and listed in FDA GUDID since 27 Oct 2022 (UDI-DI 07290016633696), 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 | Number07290016633696 | Date27 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180189 | Date1 Jun 2018 | StatusActive |
Official records
- AccessGUDID record 07290016633696
- FDA 510(k) database K180189
Across registries
- FDA 510(k) K180189 decided 1 Jun 2018 Active
- FDA GUDID UDI-DI 07290016633696 listed 27 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K180189
- Listed FDA GUDID 07290016633696
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Morpheus8V Applicator
- Generic name
- Radio-frequency skin surface treatment system applicator
- Model / Ref / Catalog
- AG609931A
- Primary DI / UDI-DI
- 07290016633696
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Radio-frequency skin surface treatment system applicator
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution