Skin photodynamic therapy/phototherapy lamp

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

Buy It Now

Available from:
CosTec Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
322320

Public Summary

Summary for ARTG Entry:

322320

CosTec Pty Ltd - Skin photodynamic therapy/phototherapy lamp

ARTG entry for

Medical Device Included Class IIb

Sponsor

CosTec Pty Ltd

Postal Address

PO Box 1036,Double Bay, NSW, 2028

Australia

ARTG Start Date

27/08/2019

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

Shanghai Apolo Medical Technology Co Ltd

Room 301-310 Building 11 388 Yindu Road

Xuhui District

, Shanghai, 200231

China

Products

1. Skin photodynamic therapy/phototherapy lamp

Product Type

Single Device Product

Effective date

27/08/2019

GMDN

59822 Skin photodynamic therapy/phototherapy lamp

Intended purpose

The HS-770 Photodynamic Therapy System is intended use in the treatment of Dermatological conditions

and specifically indicated to treat moderate inflammatory acne vulgaris, treatment of superficial, benign

vascular, and pigmented lesions, improve oily skin and acne, improve lymph circulation, the temporary

relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the

relaxation of muscle tissue; and to temporarily increase local blood circulation where applied

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 02.11.2019 at 05:55:47 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

Search alerts related to this product

Share this information