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510(k) Data Aggregation
K Number
K000693Device Name
UMECO OPTIMA MULTILINE LASER SYSTEM
Manufacturer
MEDICAL LASER SOLUTIONS LLC.
Date Cleared
2000-05-16
(76 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL LASER SOLUTIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K972368Device Name
FOTONA SKINLIGHT PLUS ND: YAG SYSTEM
Manufacturer
MEDICAL LASER SOLUTIONS
Date Cleared
1997-09-23
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL LASER SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fotona Skinlight Plus Nd: YAG system is indicated for the photocoagulation of benign vascular and pigmented lesions.
Device Description
The Fotona Skinlight Plus system is based on the addition of a Nd: YAG accessory to a previously cleared Er: YAG system (K962902). Within the accessory sub-system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of flashlamps. After the cavity,a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in noncontact mode. The System is capable of emitting up to 2.0 Watts of light at 532 nm, with a minimal pulsewidth envelope of 100ms. The laser is intended to be used for the photocoagulation of benign vascular and pigmented lesions. The Nd: YAG accessory sub-system is designed with 3 major sub-systems: a) An optical fiber delivery system terminated in spot-size specific handpiece. b) An electronic power supply and interface circuitry. c) An optical chamber containing laser rod and laser cavity optics. No accessories are available for use with the accessory Nd: Y AG sub-system.
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K Number
K970757Device Name
FOTONA SKINSCAN
Manufacturer
MEDICAL LASER SOLUTIONS
Date Cleared
1997-05-09
(67 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL LASER SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The Fotona Skinscan system is a microprocessor controlled device which generates precisely defined patterns on skin tissue in an automated sequence to increase uniformity and ease of treatment when used in conjunction with a host Skinlight system. The Fotona Skinscan system is designed as an accessory for use with the Fotona Skinlight laser system. Skinscan is functionally integrated to the host laser system. When the scanner head is attached to the articulated arm and the scanner cable is connected, the host laser system recognizes the presence and activation of the accessory and permits activation of the scanner specific modes which are programmed into the host at time of installation of the scanner accessory. In these modes scanner settings can be selected from an easy-toread menu. When the operator reverts to use of the standard dermatological handpiece, these settings are not accessible. When the scanner is connected and a scanner sub-menu is selected the system automatically initiates for scanner operation. The Skinscan system is designed with 3 major sub-systems a) A scanner handpiece comprising smoke evacuation components and distance gauge components. b) A scanner head, containing scanning mirrors and imaging optics. c) An electronic control hox containing scanning mirror control and laser interface circuitry.
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K Number
K962902Device Name
FOTONA SKINLIGHT LASER SYSTEM
Manufacturer
MEDICAL LASER SOLUTIONS
Date Cleared
1997-01-10
(169 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL LASER SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The laser is intended to be used for cutting, and coagulating soft tissue.
Device Description
The Fotona Skinlight system is based on Er: Y AG laser technology. Within the system, an optical cavity contains the Er: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in noncontact mode. The System is capable of emitting up to 1.0 Joule of pulsed light at 2.94 um, with a (nominal ) pulsewidth of 300 us. The Skinlight system is designed with 5 major sub-systems: a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse. b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger. c) An Er:YAG laser rod, capable of generating 1.0 Joule optical pulses at a frequency up to 15 Hz. d) An optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece. e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
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