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510(k) Data Aggregation
K Number
K001223Device Name
ACULUX, MODEL AX3001, AX3002
Manufacturer
Date Cleared
2000-06-23
(67 days)
Product Code
Regulation Number
878.4580Why did this record match?
Product Code :
FQP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K993314Device Name
SYNTHES LIGHT GUIDE
Manufacturer
Date Cleared
1999-12-06
(63 days)
Product Code
Regulation Number
878.4580Why did this record match?
Product Code :
FQP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Synthes Light Guide is intended to transmit light to illuminate a surgical site during surgical procedures
Device Description
The subject Synthes Light Guide uses a single 'fiberoptic' quartz fiber encased by medical grade stainless steel to externally illuminate a surgical site during surgical procedures. This light carrier is connected via standard adapters to currently marketed fiberoptic light cables which are sequentially connected to currently marketed Xenon or Halogen light sources. The materials and components of the Synthes Light Guide do not have patient contact or body fluid contact and therefore biocompatibility testing is not applicable. The device is approximately 310mm in length and 6mm in diameter. It is designed to be affixed via clamps to a ring retractor system which positions the device above the surgical site during a surgical procedure.
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