Identity
- Trade Name
- Density B-Tip FDA UDI
- Generic Name
- Radio-frequency skin/body contouring system FDA UDI
- Device Name
- Density B-Tip FDA UDI
- Model / Reference
- Density B-Tip FDA UDI
- Description
- Density B-Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800020104250 FDA UDI
- 510(k) Number
- K230663 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency skin/body contouring system
Density B-Tip by Jeisys Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230663 also covers:
- DENZA B-Tip II — Jeisys Medical Inc.
- DENZA F-Tip — Jeisys Medical Inc.
- DENZA Handpiece — Jeisys Medical Inc.
- DENZA I-Tip — Jeisys Medical Inc.
- DENZA I-Tip II — Jeisys Medical Inc.
- DENZA Main body — Jeisys Medical Inc.
- DENZA TIP SET — Jeisys Medical Inc.
- Density B-Tip II — Jeisys Medical Inc.
- Density F-Tip II — Jeisys Medical Inc.
- Density Handpiece — Jeisys Medical Inc.
- Density I-Tip — Jeisys Medical Inc.
- Density I-Tip II — Jeisys Medical Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jeisys Medical Incorporated
Sources (1)
- FDA UDI 2bfcb424-45c5-47bd-b731-286e12279b7e 34 fields · synced Jun 6, 2026