INTRAgen Tip KT-15
by Jeisys Medical Incorporated 2 variants
INTRAgen Tip KT-15 is a Class II device made by Jeisys Medical Incorporated, cleared under FDA 510(k) K142833 on 4 Jun 2015 and listed in FDA GUDID since 29 Mar 2022 (UDI-DI 08800020101211), 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 | Number08800020101211 | Date29 Mar 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142833 | Date4 Jun 2015 | StatusActive |
Official records
- AccessGUDID record 08800020101211
- FDA 510(k) database K142833
Across registries
- FDA 510(k) K142833 decided 4 Jun 2015 Active
- FDA GUDID UDI-DI 08800020101211 listed 29 Mar 2022 Listed
Timeline
- Cleared FDA 510(k) K142833
- Listed FDA GUDID 08800020101211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- INTRAgen Tip
- Generic name
- Radio-frequency skin contouring system applicator tip
- Model / reference
- KT-15
- Primary DI / UDI-DI
- 08800020101211
- 510(k) Number
- FDA product code
- OUH, 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.