Diode Laser Wolf 445nm

FDA UDI

Class II (US FDA UDI)

by A.R.C. Laser AG

Identity

Trade Name: Diode Laser Wolf 445nm FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: Wolf 445nm, Diode Laser, Aiming Beam 532nm, Coupling U.C. FDA UDI
Model / Reference: LS11000 FDA UDI
Description: Wolf 445nm, Diode Laser, Aiming Beam 532nm, Coupling U.C. FDA UDI

Identifiers

Catalog Number: LS11000 FDA UDI
Primary DI / UDI-DI: 04260155592546 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: General/multiple surgical diode laser 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

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

MRI Safety

MR Unsafe FDA UDI

Category: General/multiple surgical diode laser system

Diode Laser Wolf 445nm by A.R.C. Laser AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: A.R.C. Laser AG

Sources (1)

FDA UDI 6f3dc886-fa9e-44e8-a1d0-de148cb39d60 34 fields · synced Jun 1, 2026