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510(k) Data Aggregation
K Number
K010046Device Name
NUVOLASE 532 MEDICAL LASER SYSTEM
Manufacturer
Date Cleared
2001-04-05
(90 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN LASER CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K990665Device Name
BQ/BM INTEGRATED LASER DELIVERY SYSTEM
Manufacturer
Date Cleared
1999-05-17
(76 days)
Product Code
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN LASER CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended as a laser delivery system for use by an opthalmologist in the treatment of ocular tissue.
1. RETINAL PHOTOCOAGULATION
2. TRABECULOPLASTY
Device Description
When connected by fiber optic to a laser and properly attached to a 900 BQ or 900 BM slit lamp, the device directs and focuses laser energy on target tissue parfocally with the slit lamp image. An operator protective filter is incorporated into te device. The spot diameter is user adjustable, and the filter is removable to permit unimpaired viewing through the slit lamp microscope.
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K Number
K990725Device Name
NUVOLASE 532 LASER SYSTEM
Manufacturer
Date Cleared
1999-03-22
(17 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN LASER CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
RETINAL AND MACULAR PHOTOCOAGULATION
TRABECULOPLASTY
Device Description
The Nuvolase 532 Laser System for Ophthalmology is a continuous-wave frequency-doubled diode-pumped Nd:YAG laser system. Treatement beam power output for the system is 50 milliwatts to 1.5 watts at a wavelength of 532 nm. Depending on the delivery device efficiency, the maximum power level may be as much as 2.0 Watts CW. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure durations for the Nuvolase 532 Laser System for Ophthalmology (in seconds) are 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via fiber optic and laser slit lamp.
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