Define System AG612444A
Define System AG612444A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K242598 on 14 Nov 2024 (1 earlier submission) and listed in FDA GUDID since 7 Jan 2025 (UDI-DI 07290016633573), 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 | Number07290016633573 | Date7 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK242598 | Date14 Nov 2024 | StatusActive |
Official records
- AccessGUDID record 07290016633573
- FDA 510(k) database K242598
- FDA 510(k) database K191855
Across registries
- FDA 510(k) K242598 decided 14 Nov 2024 Active
- FDA GUDID UDI-DI 07290016633573 listed 7 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K191855
- Cleared FDA 510(k) K242598
- Listed FDA GUDID 07290016633573
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Define System
- Generic name
- Radio-frequency skin surface treatment/fat liquefaction system control unit
- Model / Ref / Catalog
- AG612444A
- Primary DI / UDI-DI
- 07290016633573
- FDA product code
- NUV, ISA, GEI, PBX
- GMDN term
- Radio-frequency skin surface treatment/fat liquefaction system control unit
- Device class
- Class II
- Regulation number
- 878.4810, 890.5660, 878.4400
- GUDID distribution status
- In Commercial Distribution
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