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510(k) K991572

ISOLUX SURGICAL HEADLIGHT by Isolux America — Product Code FST

K991572 is an FDA 510(k) premarket notification submitted by Isolux America for the device "ISOLUX SURGICAL HEADLIGHT". The FDA issued a decision of Substantially Equivalent on July 8, 1999. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Isolux America has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1999
Date Received
May 5, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Isolux America

  • K022384 — XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP (October 18, 2002)
  • K991208 — ENDOSCOPIC FIBEROPTIC CABLE (June 23, 1999)

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)
  • K102266 — ISOLED AC-POWERED LED HEADLIGHT SYSTEM (September 24, 2010)
  • 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)

FDA data resources