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K Number
K132614Device Name
PEREGRINE CURVED ILLUMINATING LASER PROBE
Manufacturer
PEREGRINE SURGICAL, LTD.
Date Cleared
2013-11-14
(85 days)
Product Code
HQB
Regulation Number
886.4690Why did this record match?
Applicant Name (Manufacturer) :
PEREGRINE SURGICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.
Device Description
Peregrine's 25ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, a Delrin handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an actylic fiber with PVC jacket and an aluminum illumination connector. Both connectors plug into existing laser and light sources.
The Laser Probe can only be used in combination with a medical laser in the Vis-NIR transmission range of 532nm to 810mm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The light portion of the device is designed for use with the Alcon Constellation Vision System. The Constellation uses a 50 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 400nm to 700mm.
The outer dimension of the glass fiber to be used in the proposed device is 98 microns or about .004 inches, which is about 25% of the size of the glass fiber in Peregrine's predicate device.
The acrylic fiber that will be used has an outer dimension of 254 microns or .01 inches, which is 25% of the size of the acrylic fiber used in the predicate device. The decrease in size of both fibers has created an acceptable device.
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K Number
K122905Device Name
PEREGRINE 23GA CURVED LASER PROBE
Manufacturer
PEREGRINE SURGICAL, LTD.
Date Cleared
2013-04-30
(221 days)
Product Code
HQB
Regulation Number
886.4690Why did this record match?
Applicant Name (Manufacturer) :
PEREGRINE SURGICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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