Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Corneal inlay
ARTG entry for
Medical Device Included Class IIb
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
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.
32 Discovery Suite 200 Irvine
, CA, 92618
United States Of America
1. Corneal inlay
Single Device Product
47959 Corneal inlay
A sterile implantable device inserted into the natural cornea to treat presbyopia [age-related hyperopia (far
sightedness)]. It is typically made of plastic material and is shaped as a thin annulus (disc) formed to fit the
curvature of the cornea; it includes a central opening that restricts the optical aperture of the eye to
increase depth of field. It is intended for long-term implantation and is surgically inserted in an intrastromal
pocket or flap made by a keratome or an appropriate laser.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:13:37 AEDT
This is not an ARTG Certificate document.
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