Summary for ARTG Entry:
Henry Schein Halas - Multi-wavelength oral examination light
ARTG entry for
Medical Device Included Class 1
Henry Schein Halas
Locked Bag 5003,ALEXANDRIA, NSW, 2015
ARTG Start Date
Medical Device Class 1
- 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.
1816 Colonial Village Lane
LANCASTER, PA, 17601
United States Of America
1. Multi-wavelength oral examination light
Medical device system
60827 Multi-wavelength oral examination light
Intended to be used by qualified health-care providers to enhance the identification and visualization of
oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or
premalignant dysplasis. It allows for conventional oral mucosal examination and excites the tissues with
multispectral lights for direct visualization of the resulting natural tissue fluoroscence and reflectance with
No Specific Conditions included on Record
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Produced at 10.11.2017 at 10:26:19 AEDT
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