Promoitalia Laser

FDA UDI

Class II (US FDA UDI)

by Promoitalia Llc

Identity

Trade Name: Promoitalia Laser FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: 1940nm Medical Diode Laser FDA UDI
Model / Reference: iLaser 1940 FDA UDI
Description: 1940nm Medical Diode Laser FDA UDI

Identifiers

Catalog Number: IL1940 FDA UDI
Primary DI / UDI-DI: 00850067051008 FDA UDI
510(k) Number: K230274 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

Promoitalia Laser by Promoitalia Llc — 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: Promoitalia Llc

Sources (1)

FDA UDI 87885d45-2965-49ce-9bf4-70753839926c 37 fields · synced May 30, 2026