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Found 9 results
510(k) Data Aggregation
K Number
K050980Device Name
ULTRASONIC BIO-MICROSCOPE, MODEL P60
Manufacturer
PARADIGM MEDICAL INDUSTRIES, INC.
Date Cleared
2005-05-26
(37 days)
Product Code
IYO, ITX
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
PARADIGM MEDICAL INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To acquire and display high resolution images of the anterior segment of the eye.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (B-Mode)
Device Description
The Model P60 UBM is a PC-based digital instrument that utilizes ultrasonic energy to generate various images of the eye. The pulser circuitry is designed to accept information from the user via a graphical user interface provided by the software. The pulser generates signals specific to the probe installed. The signal acquired from the transducer is translated into an image that is displayed on an LCD monitor.
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K Number
K023245Device Name
BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
Manufacturer
PARADIGM MEDICAL INDUSTRIES, INC.
Date Cleared
2002-10-21
(21 days)
Product Code
NJJ
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
PARADIGM MEDICAL INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tonometry for Measuring and Recording Intraocular Pressures and Intraocular Pressure Pulse Amplitudes, Pulsatile Ocular Blood Flow, Pulsatile Ocular Blood Volume, Pulsatility Index Equivalent (PEQ).
Device Description
The Paradigm Medical Industries, Inc. Blood Flow Analyzer (BFA) is an electronic pneumatic tonometer capable of measuring and recording the intraocular pressure. The pressure measurements are made at a rate of 200 times per second over a period of 5-15 seconds. Contact with the eye is by means of a sterilized single-use per patient probe having an integral membrane that isolates the cornea from the internal pneumatic operation of the BFA. The pulsatile ocular blood flow is derived from the intraocular pressure measurements acquired with the pneumatic tonometer using mathematical equations that link intraocular pressure to ocular volume change and volume flow.
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K Number
K003318Device Name
PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
Manufacturer
PARADIGM MEDICAL INDUSTRIES, INC.
Date Cleared
2001-05-22
(210 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PARADIGM MEDICAL INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003141Device Name
UBM PLUS, MODEL P45
Manufacturer
PARADIGM MEDICAL INDUSTRIES, INC.
Date Cleared
2000-12-05
(56 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
PARADIGM MEDICAL INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002228Device Name
PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X
Manufacturer
PARADIGM MEDICAL INDUSTRIES, INC.
Date Cleared
2000-10-06
(74 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PARADIGM MEDICAL INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K981109Device Name
QUITETIP
Manufacturer
PARADIGM MEDICAL INDUSTRIES, INC.
Date Cleared
1998-06-09
(74 days)
Product Code
HQC
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
PARADIGM MEDICAL INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QuiteTip™ I/A handpiece and tips are used in ophthalmic surgery to provide controlled aspiration of lens tissue while maintaining anterior chamber shape by replacing aspirated fluids with BSS.
Device Description
I/A Handpiece and Tips
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K Number
K974719Device Name
PHACOPAK
Manufacturer
PARADIGM MEDICAL INDUSTRIES, INC.
Date Cleared
1998-01-20
(33 days)
Product Code
HQC
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
PARADIGM MEDICAL INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paradigm Phaco Tip is intended to be used in conjunction with an ultrasonic handpiece for ophthalmic surgery to remove cataract tissue.
Device Description
Not Found
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K Number
K971795Device Name
AUTOMATED CHAMBER MAINTENANCE MODULE
Manufacturer
PARADIGM MEDICAL INDUSTRIES, INC.
Date Cleared
1997-07-14
(60 days)
Product Code
HQC
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
PARADIGM MEDICAL INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ACM Module is an accessory device incorporated in the aspiration line behind the handpiece to neutralize vacuum surge during phacoemulsification.
Device Description
Not Found
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K Number
K970887Device Name
BLOOD FLOW ANALYZER
Manufacturer
PARADIGM MEDICAL INDUSTRIES, INC.
Date Cleared
1997-06-17
(98 days)
Product Code
HKY
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
PARADIGM MEDICAL INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A tonometer and acsessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. We intend the device for use in the diagnosis of glaucoma.
Device Description
A tonometer and accessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. We intend the device for use in the diagnosis of glaucoma.
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