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Found 7 results
510(k) Data Aggregation
K Number
K994362Device Name
HEADLAMP HL2000.
Manufacturer
ANGIOLAZ, INC.
Date Cleared
2000-05-11
(136 days)
Product Code
FSR
Regulation Number
886.4335Why did this record match?
Applicant Name (Manufacturer) :
ANGIOLAZ, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Headlamp HL2000 has indicated use in the following situations:
There is a requirement for illuminating a surgical field. .
· There is a requirement for munimaling on and The doctor wears this device on hishler end to the headlamp. The headlamp contains a
end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.
Device Description
The doctor wears this device on hishler end to the headlamp. The headlamp contains a end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.
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K Number
K992447Device Name
50 W METAL HALIDE ILLUMINATOR, VES 0501.
Manufacturer
ANGIOLAZ, INC.
Date Cleared
1999-10-20
(90 days)
Product Code
FCW, FCR, FFS, GCT
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ANGIOLAZ, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 50 W Metal Halide Illuminator has indicated use in the following situations:
- There is a requirement for illuminating medical headlamps.
- There is a requirement for fiber-optic illumination for endoscopy applications.
- There is a requirement to use video as a visual aid or a method of recording or both.
- There is a requirement for any or all of the above at the same time.
Device Description
Not Found
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K Number
K982397Device Name
VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
Manufacturer
ANGIOLAZ, INC.
Date Cleared
1998-09-10
(63 days)
Product Code
FWF
Regulation Number
878.4160Why did this record match?
Applicant Name (Manufacturer) :
ANGIOLAZ, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VES 3001-m use is indicated whenever video display from an endoscope is required for more convenient viewing.
Device Description
Not Found
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K Number
K982409Device Name
VES 1501-M
Manufacturer
ANGIOLAZ, INC.
Date Cleared
1998-08-21
(42 days)
Product Code
FWF
Regulation Number
878.4160Why did this record match?
Applicant Name (Manufacturer) :
ANGIOLAZ, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VES 1501-m use is indicated whenever video display from an endoscope is required for more convenient viewing.
Device Description
Not Found
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K Number
K981819Device Name
ANGIOLAZ VES-1CAM
Manufacturer
ANGIOLAZ, INC.
Date Cleared
1998-08-04
(74 days)
Product Code
FWF
Regulation Number
878.4160Why did this record match?
Applicant Name (Manufacturer) :
ANGIOLAZ, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VES-1CAM use is indicated when ever there is a need for the use of video in endoscopic procedure.
Device Description
Not Found
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K Number
K981821Device Name
VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
Manufacturer
ANGIOLAZ, INC.
Date Cleared
1998-07-29
(68 days)
Product Code
FSS
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
ANGIOLAZ, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VES 3001/w use is indicated in the following situations:
- Whenever there is a need for head lamp illumination of the fiber-optic type .
- When ever there is a need for a fiber-optic illuminator for an endoscope .
- . When ever there is a need to use video either as a visual aid for as a method of recording or both.
- When ever there is a requirement for any or all of the above at the same . time.
Device Description
Not Found
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K Number
K981827Device Name
VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
Manufacturer
ANGIOLAZ, INC.
Date Cleared
1998-07-28
(67 days)
Product Code
FET
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ANGIOLAZ, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VES0281-m is for use as a visual aid for an endoscope when doing diagnostic evaluations or procedures.
Device Description
The functional package of this unit is as safe as separated components used for general endoscopy. The illuminator for all such systems presents the biggest question mark. This system utilizes a low wattage (28 watt) lamp instead of the usual 150 watt or 300 watt lamp usually used for such applications. This lower wattage provides several safety advantages:
- Longer life (150 hours vs. typically 40 hours).
- Low energy at the light guide end virtually eliminating problems with burning and end tip heating which is common with other systems. (The system has the same hot mirror configuration as other systems.)
- 3400% color temperature.
- Better utilization of the available light because the filament is smaller and capable of being focused to a smaller point on the fiber optic bundle.
The fact that the system is completely pre-wire internally eliminates delays in a procedure because the video equipment was not connected correctly. The use of a single cord minimizes potential problems with tripping over multiple cords.
The fully assembled system meets the current UL544 current leakage requirements.
The effectiveness of this unit is the same as multi-component set ups when used with more conventional 1/2" CCD sensors and 150 watt illuminators which is a common combination especially for office applications, into which this system will be marketed.
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