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510(k) K052979

1125 XSB XENON FIBER-OPTIC LIGHT SOURCE by Isolux, LLC — Product Code HBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2005
Date Received
October 24, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Illuminator, Fiberoptic, Surgical Field
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

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  • K163185 — OptiLux LED Illuminator (November 21, 2016)
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  • K111342 — LIGHT GUIDE CABLE (November 25, 2011)
  • K021931 — ENDOSCOPIC FIBEROPTIC CABLE (September 6, 2002)
  • K991208 — ENDOSCOPIC FIBEROPTIC CABLE (June 23, 1999)
  • K983277 — LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (December 16, 1998)
  • K933593 — LUMINOUS 150 FIBEROPTIC ILLUMINATOR (October 28, 1993)
  • K922837 — S1500 XENON LIGHT SOURCE (November 3, 1992)
  • K922462 — NEXTEC FIBEROPTIC CABLES (September 21, 1992)