Surgical frequency-doubled Nd:YAG laser system

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Velocity 8 Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
290740

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Public Summary

Summary for ARTG Entry:

290740

Velocity 8 Pty Ltd - Surgical frequency-doubled Nd:YAG laser system

ARTG entry for

Medical Device Included Class IIb

Sponsor

Velocity 8 Pty Ltd

Postal Address

Level 4 / 257 Clarence Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

28/06/2017

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Laseroptek Co Ltd

204 Hyundai l valley 31 Galmachi-ro

244beon-gil Jungwon-gu

Seongnam-si, Gyeonggi-do, 13212

Korea - Republic of

Products

1. Surgical frequency-doubled Nd:YAG laser system

Product Type

Medical device system

Effective date

28/06/2017

GMDN

36150 Surgical frequency-doubled Nd:YAG laser system

Intended purpose

Dermatology laser for tattoo removal, treatment of pigmented lesions and treatment of other skin

conditions including psoriasis and vitiligo.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 03.11.2017 at 02:58:36 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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