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Cellfina Prep Pack

FDA UDI

Class II (US FDA UDI)

by Ulthera Inc

Identity

Trade Name
Cellfina Prep Pack FDA UDI
Generic Name
Mechanical skin contouring system injection/transection set FDA UDI
Model / Reference
CP1 Rev G FDA UDI

Identifiers

Primary DI / UDI-DI
00840763100803 FDA UDI
510(k) Number
K161885 FDA UDI
FDA Product Code
OUP FDA UDI
GMDN Term
Mechanical skin contouring system injection/transection set 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mechanical skin contouring system injection/transection set

Cellfina Prep Pack by Ulthera Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical skin contouring system injection/transection set.

Cleared under the same submission

K161885 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ulthera Inc

Sources (1)

  • FDA UDI b254b128-ca6d-421c-b507-1aba062e4a3a 33 fields · synced May 31, 2026