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510(k) Data Aggregation
K Number
K990780Device Name
NUVOLASE 532 CUTANEOUS LASER SYSTEM
Manufacturer
AMERICAN LASER MEDICAL
Date Cleared
1999-03-22
(13 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN LASER MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nuvolase 532 Laser System for Ophthalmology is intended for use in the treatment of vascular lesions of the skin, including capillary hemangioma (port wine stain), strawberry hemangioma, telangiectasia, and rosacea. It is also intended for pigmented lesions including freckles, age spots, café-au-lait, and lentigo.
Device Description
The Nuvolase 532 Cutaneous Laser System is a continuous-wave frequencydoubled diode-pumped Nd: Y AG laser system. Treatement beam power output for the system is 50 milliwatts to 1.5 watts at a wavelength of 532 nm. The maximum power level to tissue is 2.5 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 handpiece.
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K Number
K972765Device Name
NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER
Manufacturer
AMERICAN LASER MEDICAL
Date Cleared
1997-10-21
(89 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN LASER MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NuvoLase 720 Laser System is intended for use in retinal and macular photocoagulation, trabeculoplasty, and iridotomy.
Device Description
The NuvoLase Model 720 is a continuous wave argon ion laser system, emitting a maximum of 2.5 watts, primarily at 488 nm and 514.5 nm wavelengths. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 720 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via Rodenstock RO 5000 LS laser slit lamp, connected by fiber optic.
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K Number
K972561Device Name
NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY
Manufacturer
AMERICAN LASER MEDICAL
Date Cleared
1997-10-06
(89 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN LASER MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Retinal and Macular photocoagulation
2. Trabeculoplasty
Device Description
The NuvoLase Model 660 is a continuous wave frequency-doubled diode-pumped Nd: YAG laser system. Treatment beam power output for the NuvoLase 660 laser is adjustable to a maximum of 2.0 Watts continuous wave at 532 nm. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 660 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via Rodenstock RO 5000 LS laser slit lamp, connected to the laser by fiber optic.
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K Number
K970667Device Name
NUVO-LASE 660 LASER SYSTEM
Manufacturer
AMERICAN LASER MEDICAL
Date Cleared
1997-05-13
(78 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN LASER MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nuvo-Lase 660 Laser System is intended for use in the treatment of selected vascular and pigmented lesions of the skin. Laser light is used to photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue. The Nuvo-Lase 660 Laser System is intended for in use the treatment of selected pigmented and vascularized lesions of the skin. Representative indications for use are: For vascular lesions: (Green - 532 nm) 1. Capillary Hemangioma (port wine hemangioma) 2 . Strawberry hemangioma 3. Telangiectasia 4 . Rosacea For pigmented lesions: (Green - 532 nm). 1. Freckles 2. Age Spots 3. Cafe-au-lait 4 . Lentigo
Device Description
The Nuvo-Lase 660 Laser System submission covers all of the internal parts, subassemblies and components as well as the completed device. The Nuvo-Lase Model 660 is a continuous wave frequency-doubled Nd:YAG laser system with output at 532 nm. Treatment beam output for the Nuvo-Lase 660 laser 3 Watts continuous wave at 532 nm. The aiming beam is provided by an adjustable intensity incoherent white light source. Exposure times for the Nuvo-Lase 660 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Laser activation occurs by footswitch. Overall weight of the dimensions of 10 X 14 X 5 inches (25 X 36 X 13 Cm). The electrical power requirement is 115 VAC 15 amp single phase. The system is air-cooled by fans. Accessories available for use with the Nuvo-Lase 660 Laser include a focusing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Nuvo-Lase 660 Laser System is not a computer controlled device.
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K Number
K963389Device Name
FLEX-LASE 600 SERIES ION LASER SYSTEM
Manufacturer
AMERICAN LASER MEDICAL
Date Cleared
1996-11-26
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN LASER MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flaxelase 600 Series Ion Laser is intended for use in the treatment of selected yascular and pigmented lesions of the skin. Laser light of a selected wavelength is used to photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue.
Flex-Lase 600 Ion Laser is intended for use in the the a treatment of salected pigmented and vascularized lesions of the skin. Representative indications for use are:
Flex-Lase Model 640 Laser System For vascular lesions: (Yellow - 568 nm)
1. Capillary Hemangioma (port wine hemangioma)
2. Strawberry hemangioma
3. Telangectasia
4. Rosacea
For pigmented lesions: (Yellow/Green - 568 nm and 520-530 nm).
1. Freckles
2. Age Spots
3. Cafe-au-lait
4. Lentigo
Flex-Lase Model 620 Laser System For Wascular Sesions: (Blue/Green - 488 nm and 514.5 nm)
1. Capillary Hemangioma (port wine hemangioma)
2. Strawberry Hemangioma
3. Telangectasia
4. Rosagea .
For pigmented lesions: (Green - p14.5 mm)
1. Freckles
2. Age Spots
3. Cafe-Au-Lait
4. Lentigo
Device Description
The Flex-Lase 600 Series Ion Laser submission covers all of the internal parts, subassemblies and components as well as the completed device. The Flex-Lase Model 640 is a coninuous wave krypton laser system emitting light at the 568 nm (yellow) and 520/530 nm (green) wavelengths. The Flex-Lase Model 620 is a continuous wave argon laser system emitting light at the 488 nm (blue) and the 514 nm (green) wavelengths.
Treatment beam output for the Flex-Lase Model 640 (krypton) is 1.0 Watt (yellow) and 3.0 Watts (yellow-green simultaneous). The power output for the Flex-Lase Model 620 (argon) is 5.5 watts blue-green or 2.0 watts green. The aiming beam is provided by an adjustable intensity incoherent white light source. Exposure times for the Flex-Lase 600 Series Ion Laser (in seconds) are 0.02, 0.05, 0.1. 0.25, 0.5, 1.0, and continuous.
Laser activation occurs by footswitch. Overall weight of the system is 112 lbs. (51 kg). The Flex-Lase 600 Series Ion Laser has a footprint of 16 X 24 inches (38 X 60 cm) and is 36 inches (90 cm) high.
The electrical power requirement is 208 VAC 40 amb single phase. Cooling is provided by external filtered flow-through tap water at a minimum rate of 2.5 gallons (9,5 liters) per minute.
Accessories available for use with the Flex-lase 600 Ton Laser include a fooysing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Flex-laser 600 series is not a computer controlled device.
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