IRIDEX 810 Laser

FDA UDI

Class II (US FDA UDI)

by Iridex Corporation

Identity

Trade Name: IRIDEX 810 Laser FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: The Iridex 810 Laser is a semiconductor diode laser system that delivers pulsed 810nm infrared laser light intended to be used for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other laser diode treatments. FDA UDI
Model / Reference: 22000 FDA UDI
Description: The Iridex 810 Laser is a semiconductor diode laser system that delivers pulsed 810nm infrared laser light intended to be used for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other laser diode treatments. FDA UDI

Identifiers

Primary DI / UDI-DI: 00813125016654 FDA UDI
510(k) Number: K202760 FDA UDI
FDA Product Code: GEX FDA UDI
HQF 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
886.4390 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

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Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General/multiple surgical diode laser system

IRIDEX 810 Laser by Iridex Corporation — 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: Iridex Corporation

Sources (1)

FDA UDI 06b07f17-b7ef-4b22-8970-40611e287ddd 35 fields · synced Jun 9, 2026