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PelleFirm VariPack

FDA UDI

Class II (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name
PelleFirm VariPack FDA UDI
Generic Name
Radio-frequency skin contouring system applicator, monopolar FDA UDI
Device Name
PelleFirm VariPack FDA UDI
Model / Reference
P3PFVP-WMHU FDA UDI
Description
PelleFirm VariPack FDA UDI

Identifiers

Primary DI / UDI-DI
00841494108250 FDA UDI
510(k) Number
K132949 FDA UDI
FDA Product Code
PBX FDA UDI
GMDN Term
Radio-frequency skin contouring system applicator, monopolar FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radio-frequency skin contouring system applicator, monopolar

PelleFirm VariPack by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency skin contouring system applicator, monopolar.

Cleared under the same submission

K132949 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cynosure, LLC

Sources (1)

  • FDA UDI 7e38cd03-e4ea-43a0-8081-d4ee83fedae8 34 fields · synced May 31, 2026