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HR Hand piece

FDA UDI

Class II (US FDA UDI)

by Viora Ltd

Identity

Trade Name
HR Hand piece FDA UDI
Generic Name
Intense pulsed light skin surface treatment system FDA UDI
Device Name
HR Hand piece FDA UDI
Model / Reference
VTR2001 FDA UDI
Description
HR Hand piece FDA UDI

Identifiers

Catalog Number
VTR2001 FDA UDI
Primary DI / UDI-DI
07290016746365 FDA UDI
510(k) Number
K090399 FDA UDI
FDA Product Code
ONF FDA UDI
GMDN Term
Intense pulsed light skin surface treatment system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intense pulsed light skin surface treatment system

HR Hand piece by Viora Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intense pulsed light skin surface treatment system.

Cleared under the same submission

K090399 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Viora Ltd

Sources (1)

  • FDA UDI a6ecb94a-cd16-495d-946e-007af06fbb05 36 fields · synced May 30, 2026