23ga Flexible Tapered Laser Probe - Alcon Compatible

FDA UDI

Class II (US FDA UDI)

by Vortex Surgical, Inc.

Identity

Trade Name: 23ga Flexible Tapered Laser Probe - Alcon Compatible FDA UDI
Generic Name: Ophthalmic laser system beam guide FDA UDI
Device Name: 23ga Flexible Tapered Laser Probe - Alcon Compatible FDA UDI
Model / Reference: VS0130.23A FDA UDI
Description: 23ga Flexible Tapered Laser Probe - Alcon Compatible FDA UDI

Identifiers

Catalog Number: VS0130.23A FDA UDI
Primary DI / UDI-DI: B384VS013023A1 FDA UDI
510(k) Number: K021696 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Ophthalmic laser system beam guide FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 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

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

Yes

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 23 Gauge FDA UDI

Category: Ophthalmic laser system beam guide

23ga Flexible Tapered Laser Probe - Alcon Compatible by Vortex Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic laser system beam guide.

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23-27G BriteLight™ Angled 45° EndoProbe® Box of 6 — Iridex Corporation · Class II
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OtoProbe™ Short Angled Box of 6 — Iridex Corporation · Class II

Cleared under the same submission

K021696 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: Vortex Surgical, Inc.

Sources (1)

FDA UDI 6d9c7143-5843-439b-8f28-b5d32026ac0a 37 fields · synced Jun 8, 2026