Light therapy unit, infrared

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

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Available from:
OzMask
Class:
Class 1
Authorization status:
Included
Authorization number:
323697

Public Summary

Summary for ARTG Entry:

323697

OzMask - Light therapy unit, infrared

ARTG entry for

Medical Device Included Class 1

Sponsor

OzMask

Postal Address

Suite 903 10 Help Street,Chatswood, NSW, 2067

Australia

ARTG Start Date

17/09/2019

Product category

Medical Device Class 1

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

Liaoning Upcera Co Ltd

No122 Xianghuai Road Economic Development

Zone

Benxi, Liaoning, 117004

China

Products

1. Light therapy unit, infrared

Product Type

Single Device Product

Effective date

17/09/2019

GMDN

35147 Light therapy unit, infrared

Intended purpose

LED face mask designed to emit LED light in the visible and invisible spectra (wavelengths around

350mm-850nm ) including3-7 RGB lights plus infrared lighting for the cosmetic treatment of dermatological

conditions in beauty salons. The LED face mask consists of an energy generator and an attached

applicator head to apply the energy to the skin. The LED mask is operated by the user to rejuvenate the

skin, reduce pigmentation and wrinkles, renew the skin and combat acne.

Specific Conditions

© 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 08.11.2019 at 10:27:40 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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