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510(k) K904681

VLS 5300 300W XENON LIGHT SOURCE by Vistek Corp. — Product Code HBI

K904681 is an FDA 510(k) premarket notification submitted by Vistek Corp. for the device "VLS 5300 300W XENON LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on December 18, 1990. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Vistek Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1990
Date Received
October 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Vistek Corp.

  • K904682 — VISTEK ELECTRONIC CONTROLLER (December 18, 1990)
  • K871034 — LCA 2000 (April 10, 1987)
  • K860173 — VIS-2000 VIDEO SYSTEM (February 7, 1986)
  • K843806 — VIS-1000 VIDEO SYSTEM (December 12, 1984)

Other clearances for product code HBI

  • K223183 — Light-Guide Cables (January 13, 2023)
  • K163185 — OptiLux LED Illuminator (November 21, 2016)
  • 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)

FDA data resources