Klyo

FDA UDI

Class II (US FDA UDI)

by Klyo Medical Systems Inc

Identity

Trade Name: KLYO FDA UDI
Generic Name: Operating room light system FDA UDI
Device Name: Single, Double and Triple S-Series LED Surgical Light system with and without Variable Color Temperature, for normal and Low Ceiling height installation and with or without wall controls. FDA UDI
Model / Reference: KLED-S FDA UDI
Description: Single, Double and Triple S-Series LED Surgical Light system with and without Variable Color Temperature, for normal and Low Ceiling height installation and with or without wall controls. FDA UDI

Identifiers

Primary DI / UDI-DI: B773KLEDS0 FDA UDI
FDA Product Code: FSY FDA UDI
FTD FDA UDI
GMDN Term: Operating room light system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4580 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating room light system

Klyo by Klyo Medical Systems Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Klyo Medical Systems Inc

Sources (1)

FDA UDI e2818167-cb89-4703-a58d-2a89ff9728ed 34 fields · synced May 30, 2026