Alcon, Engauge

FDA UDI

Class II (US FDA UDI)

by Alcon Laboratories, Inc.

Identity

Trade Name: Alcon, Engauge FDA UDI
Generic Name: Ophthalmic laser system beam guide FDA UDI
Device Name: 20 GA Curved Illuminated Laser Probe FDA UDI
Model / Reference: 8065750985 FDA UDI
Description: 20 GA Curved Illuminated Laser Probe FDA UDI

Identifiers

Primary DI / UDI-DI: 00380657509850 FDA UDI
FDA Product Code: HQB FDA UDI
HQE FDA UDI
HQF FDA UDI
GMDN Term: Ophthalmic laser system beam guide FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4690 FDA UDI
886.4150 FDA UDI
886.4390 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ophthalmic laser system beam guide

Alcon, Engauge by Alcon Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic laser system beam guide.

CURVED LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4 — FCI S A S FCI 20 22 · Class II
25ga Stiff Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector — KATALYST SURGICAL, LLC · Class II
Synergetics — SYNERGETICS USA, INC. · Class II
23-27G BriteLight™ Angled 45° EndoProbe® Box of 6 — Iridex Corporation · Class II
OtoProbe™ Long Angled Single — Iridex Corporation · Class II
Synergetics — SYNERGETICS USA, INC. · Class II
OtoProbe™ Short Angled Box of 6 — Iridex Corporation · Class II
23G Finger Adjustable & Intuitive XR, EndoProbe® Box of 6 — Iridex Corporation · Class II

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

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

Manufacturer

Manufacturer: Alcon Laboratories, Inc.

Sources (1)

FDA UDI a7620cfc-e9c3-4e12-8add-fdc75e47312e 35 fields · synced May 30, 2026