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510(k) Data Aggregation
K Number
K050254Device Name
SPECTRA-SP CO2 LASER SYSTEM
Manufacturer
MAX ENGINEERING LTD.
Date Cleared
2005-04-15
(71 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MAX ENGINEERING LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectra-SP Laser System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery.
Device Description
The Spectra-SP Laser System consists of a self-contained console, an articulated arm delivery system, a footswitch and a pair of goggles. The Spectra-SP Laser produces a beam of coherent infrared (10.6μm) and has dual operation mode. (Continuous Wave & Char-Free)
The main console is the heart of the Spectra-SP Laser and contains the optical system (with DC-Excited Sealed-off Carbon Dioxide GAS Tube), cooling system, system controller, and power supply. The main console also includes a key switch over the power on and off, an emergency stop push button that de-energizes the system in emergency situations, and the control panel. There are 4 casters in the console base for moving.
The laser beam exits an articulated arm into a handpiece where it is focused by the final focus lens contained in the handpiece to produce a spot size at the final focal plane. The handpiece components, when inserted in the beam delivery system, change the laser beam characteristics.
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K Number
K032735Device Name
SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM
Manufacturer
MAX ENGINEERING LTD.
Date Cleared
2003-12-03
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MAX ENGINEERING LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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