Morpheus8 AG609135A_3D
Morpheus8 AG609135A_3D is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K192695 on 27 Dec 2019 and listed in FDA GUDID since 27 Oct 2022 (UDI-DI 17290016633624), 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 | Number17290016633624 | Date27 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192695 | Date27 Dec 2019 | StatusActive |
Official records
- AccessGUDID record 17290016633624
- FDA 510(k) database K192695
Across registries
- FDA 510(k) K192695 decided 27 Dec 2019 Active
- FDA GUDID UDI-DI 17290016633624 listed 27 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K192695
- Listed FDA GUDID 17290016633624
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Morpheus8
- Generic name
- Radio-frequency skin contouring system applicator tip
- Model / Ref / Catalog
- AG609135A_3D
- Primary DI / UDI-DI
- 17290016633624
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Radio-frequency skin contouring system applicator tip
- 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 contouring system applicator tip.