Visera 4k Uhd Xenon Light Source

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: VISERA 4K UHD XENON LIGHT SOURCE FDA UDI
Generic Name: Endoscopic light source unit, line-powered FDA UDI
Model / Reference: OLYMPUS CLV-S400 FDA UDI

Identifiers

Primary DI / UDI-DI: 04953170374531 FDA UDI
510(k) Number: K151011 FDA UDI
FDA Product Code: EOQ FDA UDI
GCJ FDA UDI
EOB FDA UDI
HET FDA UDI
NWB FDA UDI
FGB FDA UDI
GMDN Term: Endoscopic light source unit, line-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.4680 FDA UDI
876.1500 FDA UDI
874.4760 FDA UDI
884.1720 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

Visera 4k Uhd Xenon Light Source by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Light Sources, Fiberoptic — STEMA Medizintechnik GmbH · Class I
SPOTLIGHT ACCESS SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
Endoscope Light Source — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class I
SL-EL200 — SONOSCAPE MEDICAL CORP. · Class IIa
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

K151011 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Olympus Medical Systems Corporation

Sources (1)

FDA UDI 8fea367d-a692-4cbe-9c34-b9c6f70293af 34 fields · synced May 30, 2026