FC Applicator

FDA UDI

Class II (US FDA UDI)

by Viora Ltd

Identity

Trade Name: FC Applicator FDA UDI
Generic Name: Multi-modality skin/body contouring system FDA UDI
Device Name: FC Applicator FDA UDI
Model / Reference: VRE2003 FDA UDI
Description: FC Applicator FDA UDI

Identifiers

Catalog Number: VRE2003 FDA UDI
Primary DI / UDI-DI: 07290016746334 FDA UDI
510(k) Number: K090221 FDA UDI
FDA Product Code: NUV FDA UDI
ISA FDA UDI
ILY FDA UDI
GMDN Term: Multi-modality skin/body contouring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
890.5660 FDA UDI
890.5500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-modality skin/body contouring system

FC Applicator by Viora Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K090221 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: Viora Ltd

Sources (1)

FDA UDI c34505c9-ef44-4924-8823-61afaf157511 36 fields · synced Jun 6, 2026