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510(k) Data Aggregation
K Number
K982940Device Name
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
Manufacturer
STAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
1999-04-08
(230 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
STAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LightSheer™ is intended to effect temporary hair reduction. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
Device Description
The LightSheer™ delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable pulse energy of 8 - 32 J. The corresponding fluence delivered through the 9 x 9 mm handpiece tip is 10 - 40 J/cm2. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode lasers located in the handpiece. The handpiece tip is water-cooled to provide active skin cooling.
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K Number
K974346Device Name
STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
Manufacturer
STAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
1998-01-16
(58 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
STAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StarLight™ Pulsed Diode Array Laser System is intended for the treatment of leg veins in Dermatology and Plastic Surgery procedures.
Device Description
The StarLight system delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable fluence of 10 – 40 J/cm². The corresponding pulse energy delivered through the 9 x 9 mm handpiece tip is 8 – 32 J. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode lasers located in the handpiece. The complete system consists of a console, a footswitch, and a handpiece connected to the console with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch and handpiece trigger are depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the touch-screen on top of the console, which provides an interface to the system computer.
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K Number
K973324Device Name
STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
Manufacturer
STAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
1997-12-03
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
STAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StarLight™ Pulsed Diode Array Laser System is intended to remove hair in Dermatology and Plastic Surgery procedures.
Device Description
The StarLight™ delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable pulse energy of 8 - 32 J. The corresponding fluence delivered through the 9 x 9 mm handpiece tip is 10 - 40 J/cm. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode. The complete system consists of a console, a footswitch, and a handpiece connected to the console with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch and handpiece trigger are depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the touch-screen on top of the console, which provides an interface to the system computer.
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K Number
K960625Device Name
SPREADABLE SHEATH INTRODUCER SET
Manufacturer
NEOSTAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
1996-08-08
(177 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
NEOSTAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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