VS3 Iridium

FDA UDI

Class II (US FDA UDI)

by Visionsense Ltd.

Identity

Trade Name: VS3 Iridium FDA UDI
Generic Name: General-purpose surgical microscope FDA UDI
Device Name: VS3 Iridium - Miniature Microscope, 785nm (MMS-IR) FDA UDI
Model / Reference: 175-0012RFB FDA UDI
Description: VS3 Iridium - Miniature Microscope, 785nm (MMS-IR) FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521844681 FDA UDI
510(k) Number: K223020 FDA UDI
FDA Product Code: OWN FDA UDI
GCJ FDA UDI
GWG FDA UDI
HRX FDA UDI
GMDN Term: General-purpose surgical microscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
882.1480 FDA UDI
888.1100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose surgical microscope

VS3 Iridium by Visionsense Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K223020 also covers:

VS3 Iridium — VISIONSENSE LTD.
VS3-IR — VISIONSENSE LTD.

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: Visionsense Ltd.

Sources (1)

FDA UDI 1253de6d-1df1-482e-8436-02227427c202 35 fields · synced May 30, 2026