Evis Exera Iii Xenon Light Source

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: EVIS EXERA III XENON LIGHT SOURCE FDA UDI
Generic Name: Endoscopic light source unit, line-powered FDA UDI
Model / Reference: OLYMPUS CLV-190 FDA UDI

Identifiers

Catalog Number: N3643342 FDA UDI
Primary DI / UDI-DI: 04953170465970 FDA UDI
510(k) Number: K121959 FDA UDI
K131780 FDA UDI
FDA Product Code: FDF FDA UDI
FDS FDA UDI
NWB FDA UDI
EOQ FDA UDI
GMDN Term: Endoscopic light source unit, line-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
874.4680 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: Endoscopic light source unit, line-powered

Evis Exera Iii Xenon Light Source by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Endoscopic light source unit, line-powered.

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LED 610 Light source — Erbe Vision GmbH · Class I
SPOTLIGHT — Depuy Spine, Inc. · Class II
SL-ED10 — SONOSCAPE MEDICAL CORP. · Class I
FUJIFILM — FUJIFILM Corporation · Class II

Cleared under the same submission

K121959 also covers:

K131780 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: Olympus Medical Systems Corporation

Sources (1)

FDA UDI 2f17c4eb-49c9-49d7-a25e-4b6a045fdde3 35 fields · synced May 30, 2026