Visualase

FDA UDI

Class II (US FDA UDI)

by Medtronic Navigation, Inc.

Identity

Trade Name: Visualase FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: COMPUTER 9735940 Z440 W/VISUALASE 3.2.1 FDA UDI
Model / Reference: 9735940 FDA UDI
Description: COMPUTER 9735940 Z440 W/VISUALASE 3.2.1 FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169878181 FDA UDI
510(k) Number: K081656 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: General/multiple surgical diode laser system

Visualase by Medtronic Navigation, Inc. — 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
Ultrafast Diode Laser — DENTLIGHT INC. · Class II

Cleared under the same submission

K081656 also covers:

Visualase — MEDTRONIC NAVIGATION, INC.

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: Medtronic Navigation, Inc.

Sources (1)

FDA UDI 2a9937cb-7aa6-4f0d-accf-27059f5f44c9 35 fields · synced Jun 1, 2026