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510(k) Data Aggregation
K Number
K983543Device Name
ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM
Manufacturer
Date Cleared
1998-12-16
(68 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ARGUS PHOTONICS GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in cutting, vaporizing and coagulating soft tissue for clinical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open & endoscopic general surgery.
Device Description
Accu-Pulse 1000 is a DC excited gas-slab pulsed CO2 laser which produces 1-15 watts average power (see below for additional Surgical specifications).
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K Number
K971830Device Name
ACCU-PULSE CARBON DIOXIDE LASER SYSTEM
Manufacturer
Date Cleared
1997-08-14
(90 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ARGUS PHOTONICS GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in cutting, vaporizing and coagulating soft tissue for clinical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open & endoscopic general surger y
Device Description
Accu-Pulse is a DC excited gas-slab pulsed CO2 laser which produces 1-15 watts average power (see below for additional Surgical specifications).
Ask a Question
Ask a specific question about this device
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