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510(k) Data Aggregation
K Number
K163632Device Name
Katalyst Cyclophotocoagulation Probe
Manufacturer
Katalyst Surgical, LLC
Date Cleared
2017-06-15
(175 days)
Product Code
LQJ, FFS, MPA
Regulation Number
886.4390Why did this record match?
Product Code :
LQJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Katalyst Cyclophotocoagulation Probe is intended, when used with an infrared laser, for Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process.
Device Description
The Cycloprobe is a single use device sold sterile. The Cycloprobe is made out of one fiberoptic, one laser machine connector, one handle for surgeon manipulation, one clear tip for placement on the eye, and a protective sheath over the fiber. On the distal side, the fiberoptic is terminated by a connector that attaches to the laser machine. On the other side, it is terminated by a fiber that has a ball lens formed onto the end that protrudes slightly from the clear tip. The connector configuration is chosen based on the surgeons' laser machine requirements. The total length of the device is 7 feet.
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