Summary for ARTG Entry:
EFB Australia Pty Ltd - Cosmetic Phototherapy system, professional - Cosmetic phototherapy system,
ARTG entry for
Medical Device Included Class IIb
EFB Australia Pty Ltd
25 Burton Street,GLEBE, NSW, 2037
ARTG Start Date
Medical Device Class IIb
- 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.
Zl de la Petite Montagne Sud 3 rue de L'Aubrac
, Evry, 91017
1. Cosmetic Phototherapy system, professional - Cosmetic phototherapy system, professional
Medical device system
47705 Cosmetic phototherapy system, professional
A Polychromatic Pulsed Lamp designed to treat benign skin damage or minor anomalies exclusively on
the surface of human skin. The skin damage concerned is of the following types: vascular; port wines
stains, rosacea, or telangiectasia; pigmentary: Lentigines, Actinic Keratosis, Follicular Keratosis; Acne:
hormonal acne hyperkeratosis of the sebaceous gland; and, hair removal treatment: hirsutism, of
hypertrichosis or for the esthetical purposes.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 11:24:09 AEDT
This is not an ARTG Certificate document.
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