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Norlase LION photocoagulator

FDA UDI

Class II (US FDA UDI)

by Norlase Aps

Identity

Trade Name
Norlase LION photocoagulator FDA UDI
Generic Name
Indirect binocular laser ophthalmoscope FDA UDI
Device Name
The Norlase LION Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty FDA UDI
Model / Reference
N006-9200 FDA UDI
Description
The Norlase LION 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
05700002165428 FDA UDI
FDA Product Code
GEX FDA UDI
HQF FDA UDI
GMDN Term
Indirect binocular laser ophthalmoscope 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

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 LION 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

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Manufacturer

Manufacturer
Norlase Aps

Sources (1)

  • FDA UDI 58aea29d-cb65-461f-8942-a91ff0ec1f09 33 fields · synced May 30, 2026