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Cellfina System Disposable Procedure Kit

FDA UDI

Class II (US FDA UDI)

by Ulthera Inc

Identity

Trade Name
Cellfina System Disposable Procedure Kit FDA UDI
Generic Name
Mechanical skin contouring system injection/transection set FDA UDI
Model / Reference
Rev O FDA UDI

Identifiers

Catalog Number
CK1 FDA UDI
Primary DI / UDI-DI
00840763100827 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 System Disposable Procedure Kit 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 21324312-25a5-430f-8a1d-d6e696fce20d 34 fields · synced May 30, 2026