Home / 510(k) Clearances / K102266

510(k) K102266

ISOLED AC-POWERED LED HEADLIGHT SYSTEM by Isolux, LLC — Product Code FST

K102266 is an FDA 510(k) premarket notification submitted by Isolux, LLC for the device "ISOLED AC-POWERED LED HEADLIGHT SYSTEM". The FDA issued a decision of Substantially Equivalent on September 24, 2010. The device falls under product code FST (Light, Surgical, Fiberoptic), 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
September 24, 2010
Date Received
August 10, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Isolux, LLC

  • K163185 — OptiLux LED Illuminator (November 21, 2016)
  • K052979 — 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE (October 31, 2005)

Other clearances for product code FST

  • K200874 — TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cab (June 30, 2020)
  • K141330 — ENDO-CORD (December 15, 2014)
  • K122637 — LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 (November 1, 2012)
  • K113697 — EIGR SURGICAL ILLUMINATION SYSTEM (February 10, 2012)
  • K113330 — CABLECAP (January 12, 2012)
  • K101496 — CABLECAP MODEL: WLF, STZ, ACM (September 14, 2010)
  • K100388 — 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS (June 22, 2010)
  • K100395 — HARMONY VLED SURGICAL LIGHTNING SYSTEM (March 17, 2010)
  • K093386 — CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST (January 28, 2010)
  • K090070 — INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM (April 22, 2009)

FDA data resources