← Back to catalogue

Norlase LYNX photocoagulator

FDA UDI

Class II (US FDA UDI)

by Norlase Aps

Identity

Trade Name
Norlase LYNX photocoagulator FDA UDI
Generic Name
Ophthalmic diode laser system FDA UDI
Device Name
The Norlase LYNX photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty. FDA UDI
Model / Reference
N008-9200 FDA UDI
Description
The Norlase LYNX photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty. FDA UDI

Identifiers

Primary DI / UDI-DI
05700002165466 FDA UDI
FDA Product Code
HQF FDA UDI
GMDN Term
Ophthalmic diode laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4390 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

Yes

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Indirect binocular laser ophthalmoscopeOphthalmic diode laser system

Norlase LYNX photocoagulator by Norlase Aps — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic diode laser system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Norlase Aps

Sources (1)

  • FDA UDI 7b63adb7-1de7-45d7-8bf2-4ba767e9d54a 33 fields · synced May 30, 2026