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510(k) Data Aggregation
K Number
K980292Device Name
CATARACT LIQUEFRACTURE DEVICE
Manufacturer
ALCON LABORATORIES
Date Cleared
1998-05-19
(113 days)
Product Code
MUS
Regulation Number
886.4670Why did this record match?
Product Code :
MUS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device assists in the removal of cataracts by softening, emulsifying and aspirating the cataract
Device Description
The Liquefracture device is designed to assist ophthalmic surgeons in the removal of cateractous lenses (cataracts) for the purpose of restoration of impaired sight due to the formation of a cataract. The Liquefracture device combines the prefreatment and emulsification functions. It will be packaged into a handpiece used directly by the surgeon within the sterile field. The handpiece will be driven by a Ophthalmic Surgery system containing irrigation and aspiration functions as currently provided in cataract surgery equipment. In addition, a low power DC power source will be included in the Ophthalmic Surgery system to control the fluid heating function of the handpiece. A user interface will also be provided by the Ophthalmic Surgery system, which is placed external to the sterile environment (field) just as in most cataract surgery equipment.
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