27ga Focal Light Pipe

FDA UDI

Class II (US FDA UDI)

by Katalyst Surgical, Llc

Identity

Trade Name: 27ga Focal Light Pipe FDA UDI
Generic Name: Ophthalmic laser system beam guide FDA UDI
Device Name: V2000-27V FDA UDI
Model / Reference: V2000-27V FDA UDI
Description: V2000-27V FDA UDI

Identifiers

Primary DI / UDI-DI: 10817489025632 FDA UDI
FDA Product Code: MPA FDA UDI
GMDN Term: Ophthalmic laser system beam guide FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

Yes

FDA UDI

Category: Ophthalmic laser system beam guide

27ga Focal Light Pipe by Katalyst Surgical, Llc — 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
Engauge — Alcon Laboratories, Inc. · 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: Katalyst Surgical, Llc

Sources (1)

FDA UDI 7a7d7f12-e9ca-4108-8717-e2dd9c5d3088 33 fields · synced Jun 8, 2026