Vari-Lase® Flex laser fiber and procedure kits

FDA UDI

Class II (US FDA UDI)

by Vascular Solutions, Inc.

Identity

Trade Name: Vari-Lase® Flex laser fiber and procedure kits FDA UDI
Generic Name: Varicose vein lasing procedure kit FDA UDI
Device Name: The VARI-LASE Platinum Bright Tip laser fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein and for the treatment of incompetence and reflux of superficial veins in the lower extremity. FDA UDI
Model / Reference: 7167 FDA UDI
Description: The VARI-LASE Platinum Bright Tip laser fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein and for the treatment of incompetence and reflux of superficial veins in the lower extremity. FDA UDI

Identifiers

Primary DI / UDI-DI: M20671671 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Varicose vein lasing procedure kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Vari-Lase® Flex laser fiber and procedure kits by Vascular Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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: Vascular Solutions, Inc.

Sources (1)

FDA UDI e846b686-e417-4de9-9878-ee8a3e752ef4 35 fields · synced May 30, 2026