20GA Straight Laser Probe with Alcon adaptor

FDA UDI

Class II (US FDA UDI)

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Identity

Trade Name: 20GA Straight Laser Probe with Alcon adaptor FDA UDI
Generic Name: Ophthalmic laser system beam guide FDA UDI
Model / Reference: 7011.ALC FDA UDI

Identifiers

Catalog Number: 7011.ALC FDA UDI
Primary DI / UDI-DI: 08717872013985 FDA UDI
510(k) Number: K024061 FDA UDI
FDA Product Code: HQF FDA UDI
GMDN Term: Ophthalmic laser system beam guide 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

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

20GA Straight Laser Probe with Alcon adaptor by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA GUDID

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Also classified as Ophthalmic laser system beam guide.

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OtoProbe™ Short Angled Box of 6 — Iridex Corporation · Class II

Cleared under the same submission

K024061 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: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Sources (1)

FDA UDI 634fb9ae-ce6c-408f-bd5e-ace80c4bebf8 34 fields · synced May 31, 2026