AgeJet
510(k) K212472
AgeJet is a medical device (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Triworks Group Srl, cleared under FDA 510(k) K212472 on 7 Jul 2022, active as of 22 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 | NumberK212472 | Date7 Jul 2022 | StatusActive |
Official records
- FDA 510(k) database K212472
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEI
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K212472
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Triworks Group srl AgeJet | AgeJet | 08057168020007 | — | On the market |
| Triworks Group srl PurePlasma | PurePlasma | 08057168020083 | — | On the market |
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