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Cellfina Motor Module Device and Package
FDA UDIClass II (US FDA UDI)
by Ulthera Inc
Identity
- Trade Name
- Cellfina Motor Module Device and Package FDA UDI
- Generic Name
- Mechanical skin contouring system motor FDA UDI
- Device Name
- DI mis issued - not in use FDA UDI
- Model / Reference
- CM1 Rev D FDA UDI
- Description
- DI mis issued - not in use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840763100568 FDA UDI
- 510(k) Number
- K153677 FDA UDI
- FDA Product Code
- OUP FDA UDI
- GMDN Term
- Mechanical skin contouring system motor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4790 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cellfina Motor Module Device and Package by Ulthera Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K153677 also covers:
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
- Ulthera Inc
Sources (1)
- FDA UDI 12a29305-08d4-4b76-991b-b186a36d1ac3 35 fields · synced Jun 6, 2026