Density B-Tip II
by Jeisys Medical Incorporated
Density B-Tip II is a Class II device made by Jeisys Medical Incorporated, cleared under FDA 510(k) K250065 on 8 Jul 2025 (1 earlier submission) and listed in FDA GUDID since 29 Aug 2023 (UDI-DI 08800020104243), 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 | FDA 510(k)SESE | NumberK250065 | Date8 Jul 2025 | StatusActive |
| United States | GUDID listing | Number08800020104243 | Date29 Aug 2023 | StatusListed |
Official records
- AccessGUDID record 08800020104243
- FDA 510(k) database K250065
- FDA 510(k) database K230663
Across registries
- FDA 510(k) K250065 decided 8 Jul 2025 Active
- FDA GUDID UDI-DI 08800020104243 listed 29 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K230663
- Listed FDA GUDID 08800020104243
- Cleared FDA 510(k) K250065
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Radio-frequency skin/body contouring system
- Model / reference
- Density B-Tip II
- Primary DI / UDI-DI
- 08800020104243
- FDA product code
- GEI
- GMDN term
- Radio-frequency skin/body contouring system
- 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/body contouring system.