Visualase

FDA UDI

Class I (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: VCLAS ACC KIT 9735571 NEURO FDA UDI
Model / Reference: 9735571 FDA UDI
Description: VCLAS ACC KIT 9735571 NEURO FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169612037 FDA UDI
FDA Product Code: GAH FDA UDI
MDM FDA UDI
LXH FDA UDI
HAO FDA UDI
GMDN Term: General/multiple surgical diode laser system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
888.4540 FDA UDI
882.4535 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: General/multiple surgical diode laser system

Visualase by Medtronic Navigation, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical diode laser system.

QuadroStar PRO — Asclepion Laser Technologies GmbH · Class II
Doctor Diode Laser — LAMBDA SPA · Class II
TxCell for IQ577, H/S 900BM/BQ & CSO9900 — Iridex Corporation · Class II
Dornier MedTech — Dornier MedTech GmbH · Class II
Assy Final HS SLA IQ532 Standard Mount — Iridex Corporation · Class II
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

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 I	Pending data

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

Manufacturer

Manufacturer: Medtronic Navigation, Inc.

Sources (1)

FDA UDI 46f9bd39-078b-44ec-bd47-665c9bc2e5fd 34 fields · synced Jun 1, 2026