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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
- Model / Reference
- CM1 Rev B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840763100117 FDA UDI
- 510(k) Number
- K134010 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
- 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
Category: Mechanical skin contouring system motor
Cellfina Motor Module Device and Package by Ulthera Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical skin contouring system motor.
- Cellfina Motor Module Device and Package — Ulthera Inc · Class II
- Cellfina Motor Module Device and Package — Ulthera Inc · Class II
Cleared under the same submission
K134010 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 4c15ed85-4f18-40d5-be00-22ca45324837 33 fields · synced Jun 8, 2026