25GA Curved Laser Probe - Alcon - Short

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref GA-0042260

by Peregrine Surgical, LLC.

Identity

Trade Name: 25GA CURVED LASER PROBE EUDAMED
25GA Curved Laser Probe - Alcon - Short FDA UDI
25GA Curved Laser Probe, SMA905 FDA UDI
Generic Name: Ophthalmic laser system beam guide FDA UDI
Device Name: 25GA CURVED LASER PROBE EUDAMED
25GA Curved Laser Probe - Alcon - Short FDA UDI
25GA Curved Laser Probe, SMA905 FDA UDI
Model / Reference: GA-0042260 EUDAMEDFDA UDI
PD725.20S FDA UDI
Description: 25GA Curved Laser Probe - Alcon - Short FDA UDI
25GA Curved Laser Probe, SMA905 FDA UDI

Identifiers

Primary DI / UDI-DI: 00632307002113 EUDAMEDFDA UDI
00632307000713 FDA UDI
Basic UDI-DI: B-00632307002113 EUDAMED
510(k) Number: K024061 FDA UDI
FDA Product Code: HQF FDA UDI
GEX FDA UDI
EMDN Code: Q02040301 OCULAR ENDOPHOTOCOAGULATION FIBERS, SINGLE-USE EUDAMED
GMDN Term: Ophthalmic laser system beam guide FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 886.4390 FDA UDI
878.4810 FDA UDI
Market of Registration: Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 25 Gauge FDA UDI

Category: Ophthalmic laser system beam guide

25GA Curved Laser Probe - Alcon - Short by Peregrine Surgical, LLC. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
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

Cleared under the same submission

K024061 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Peregrine Surgical, LLC.

Sources (3)

FDA UDI 7a093180-6ab2-4b1e-b0ff-1e54845d73f7 36 fields · synced Jul 8, 2026
FDA UDI 7fb21903-aa8c-4dbd-b9d5-74fca1fd0ba8 36 fields · synced May 30, 2026
EUDAMED c86ab1ea-63cb-44e8-b63e-29b120e25e8c 61 fields · synced Jul 8, 2026