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510(k) K871034

LCA 2000 by Vistek Corp. — Product Code FTA

K871034 is an FDA 510(k) premarket notification submitted by Vistek Corp. for the device "LCA 2000". The FDA issued a decision of Substantially Equivalent on April 10, 1987. The device falls under product code FTA (Light, Surgical, Accessories), 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
April 10, 1987
Date Received
March 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Accessories
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)
  • K904681 — VLS 5300 300W XENON LIGHT SOURCE (December 18, 1990)
  • K860173 — VIS-2000 VIDEO SYSTEM (February 7, 1986)
  • K843806 — VIS-1000 VIDEO SYSTEM (December 12, 1984)

Other clearances for product code FTA

  • K150532 — Universal Light Handle Cover, Light Handle Cover (September 22, 2015)
  • K142386 — Operating Room Light Handle Adapter (September 29, 2014)
  • K133554 — SURGICAL LIGHT HANDLE COVER (April 8, 2014)
  • K133413 — IDSS SLC (January 7, 2014)
  • K112133 — OASYS SURGICAL LIGHT CONTROLLER (March 1, 2012)
  • K102791 — EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (November 23, 2010)
  • K081698 — MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) (July 30, 2008)
  • K053321 — LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (January 19, 2006)
  • K051505 — SCB/STERIS OR-LIGHT INTERFACE BOX (August 11, 2005)
  • K023704 — KSEA SCB ACC CONTROL (January 30, 2003)

FDA data resources