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Cellfina Motor Module Device and Package

FDA UDI

Class 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
No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI FDA UDI
Model / Reference
CM1 Rev C, D, E FDA UDI
Description
No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI FDA UDI

Identifiers

Primary DI / UDI-DI
00840763100384 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ulthera Inc

Sources (1)

  • FDA UDI aaa4d431-3f96-4d7f-9275-1f057e9a18f3 33 fields · synced Jun 8, 2026