SL Laser Console 220V

FDA UDI

Class II (US FDA UDI)

by Iridex Corporation

Identity

Trade Name: SL Laser Console 220V FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Model / Reference: 12730 FDA UDI

Identifiers

Primary DI / UDI-DI: 00813125016296 FDA UDI
510(k) Number: K020374 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

Category: General/multiple surgical diode laser system

SL Laser Console 220V by Iridex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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CoolLipoTM — Leoni Fiber Optics, Inc. · Class II

Cleared under the same submission

K020374 also covers:

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: Iridex Corporation

Sources (1)

FDA UDI d1e404f3-8537-4727-8c96-abd58c214af2 34 fields · synced Jun 9, 2026