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510(k) K163185

OptiLux LED Illuminator by Isolux, LLC — Product Code HBI

K163185 is an FDA 510(k) premarket notification submitted by Isolux, LLC for the device "OptiLux LED Illuminator". The FDA issued a decision of Substantially Equivalent on November 21, 2016. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Isolux, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2016
Date Received
November 14, 2016
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

Other clearances by Isolux, LLC

  • K102266 — ISOLED AC-POWERED LED HEADLIGHT SYSTEM (September 24, 2010)
  • K052979 — 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE (October 31, 2005)

Other clearances for product code HBI

  • K223183 — Light-Guide Cables (January 13, 2023)
  • K141781 — KOGENT SPETZLER LIGHTED SUCTION TUBES (April 9, 2015)
  • K111342 — LIGHT GUIDE CABLE (November 25, 2011)
  • K052979 — 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE (October 31, 2005)
  • 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)

FDA data resources