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25ga Tapered Flex Curved Illum Laser Probe, Alcon/Coherent Laser Connector

FDA UDI

Class II (US FDA UDI)

by Katalyst Surgical, Llc

Identity

Trade Name
25ga Tapered Flex Curved Illum Laser Probe, Alcon/Coherent Laser Connector FDA UDI
Generic Name
Ophthalmic fibreoptic light instrument, single-use FDA UDI
Device Name
25ga Tapered Flexible Curved Illuminated Laser Probe, Alcon/Coherent Laser Connector, Short 19ga Needle Illumination Connector, Box of 10 FDA UDI
Model / Reference
V6315-25BV FDA UDI
Description
25ga Tapered Flexible Curved Illuminated Laser Probe, Alcon/Coherent Laser Connector, Short 19ga Needle Illumination Connector, Box of 10 FDA UDI

Identifiers

Primary DI / UDI-DI
10817489024932 FDA UDI
510(k) Number
K121187 FDA UDI
FDA Product Code
HQB FDA UDI
GMDN Term
Ophthalmic fibreoptic light instrument, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4690 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

25ga Tapered Flex Curved Illum Laser Probe, Alcon/Coherent Laser Connector by Katalyst Surgical, Llc — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K121187 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Katalyst Surgical, Llc

Sources (1)

  • FDA UDI dc688c45-2822-4c50-83bb-244dc4f49a9c 35 fields · synced Jun 8, 2026