Intense pulsed light dry eye therapy unit
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
08-08-2019
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Available from:
Optimed Pty Ltd
Class:
Class IIb
Manufactured by:
Deka M E L A Srl Via Baldanzese 17, Calenzano FI, Italy, 50041 Italy
Therapeutic area:
60386 - Intense pulsed light dry eye therapy unit
Therapeutic indications:
A portable mains electricity (AC powered) device intended to treat meibomian blepharitis (dry eye syndrome) by targeting the skin surrounding the meibomian glands (around the eyelid) with intense pulsed light (IPL). It consists of a generator connected to a light-emitting handpiece, and typically includes skin contact gel and light shielding safety glasses. It is intended to be operated by a healthcare professional in a clinical setting.
Authorization status:
A
Authorization date:
2019-06-27
