InnoVoyce VYLO Cart

FDA UDI

Class II (US FDA UDI)

by InnoVoyce LLC

Identity

Trade Name: InnoVoyce VYLO Cart FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: InnoVoyce VYLO Cart FDA UDI
Model / Reference: A FDA UDI
Description: InnoVoyce VYLO Cart FDA UDI

Identifiers

Catalog Number: LC-00455 FDA UDI
Primary DI / UDI-DI: 00860011812180 FDA UDI
510(k) Number: K240159 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: General/multiple surgical diode laser system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General/multiple surgical diode laser system

InnoVoyce VYLO Cart by InnoVoyce LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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GIGAA — Wuhan Gigaa Optronics Technology Co., Ltd. · Class II
Epic S-Series Diode Laser System — Biolase, Inc. · Class II

Cleared under the same submission

K240159 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: InnoVoyce LLC

Sources (1)

FDA UDI 7c80929a-4049-4ff3-9d33-6b4413b7bd5d 36 fields · synced May 30, 2026