REGULATORY AND SAFETY

Registered, certified and made for qualified professionals

VOLTA F3 is a Class 4 laser therapy system intended for qualified healthcare professionals. This page sets out its registration and the safety basics.

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REGISTRATION AND STANDARDS

At a glance

MEDICAL DEVICE AUTHORITY, MALAYSIA

MDA registration GC6440126-238777

CERTIFICATIONS

CE, ISO 13485 and FDA marks, as shown on the Support page

INTENDED USERS

Qualified healthcare professionals

DISTRIBUTED AND SERVICED IN MALAYSIA BY

VOLTA Laser Sdn. Bhd., Kuala Lumpur

LASER SAFETY

Safe use of a Class 4 laser

Eye protection

Class 4 lasers need laser-safety precautions, including suitable eye protection for operator and patient, as set out in the instructions for use.

Trained operators

Operators should complete training before treating patients. VOLTA Academy provides it.

Clinical judgement

The clinician decides whether photobiomodulation is appropriate for a specific patient.

DOCUMENTS

Need the paperwork?

Ask us for registration documents, certificates and the instructions for use for your clinic.

Information on this page is for healthcare professionals and does not replace the instructions for use.

CONTACT

Request a VOLTA F3 demonstration

03-7499 3373 | info@voltalaser.com

VOLTA LASER SDN. BHD.

Address: 8, Jalan 12/152,

Taman Perindustrian OUG,

58200 Kuala Lumpur

Send inquiry

Call 03-7499 3373

MDA registration GC6440126-238777. VOLTA F3 is intended for use by qualified healthcare professionals. Whether photobiomodulation is appropriate for a specific patient is a decision for the clinician.