Endovascular Laser Vein System (ELVeS®) Kit

FDA UDI

Class II (US FDA UDI)

by Ceram Optec SIA

Identity

Trade Name: Endovascular Laser Vein System (ELVeS®) Kit FDA UDI
Generic Name: Varicose vein lasing procedure kit FDA UDI
Model / Reference: ELVeS® Radial® Slim Kit 4Fx11cm FDA UDI

Identifiers

Catalog Number: 101255 FDA UDI
Primary DI / UDI-DI: 04049089100290 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: 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

Category: Varicose vein lasing procedure kit

Endovascular Laser Vein System (ELVeS®) Kit by Ceram Optec SIA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Varicose vein lasing procedure kit.

Laser Surgery Fiber 550µm — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
Disposable Laser Surgery Fiber 550µm — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
Laser Surgery Fiber - Orthopaedic Surgery Fiber for PLDD — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
Laser Surgery Fiber - Radial Emission Fiber 600µm — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
VenaCure EVLT — ANGIODYNAMICS, INC · Class II
Bare Fiber — CeramOptec GmbH · Class IIa
Laser Surgery Fiber - Disposable 600 micron laser fiber — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
Laser Surgery Fiber - Dental Surgery Fiber 400µm — OBERON GMBH FIBER TECHNOLOGIES · Class IIa

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Ceram Optec SIA

Sources (1)

FDA UDI 1b3741c0-b263-4a44-84c1-7aa9ae59e6a3 33 fields · synced Jun 6, 2026