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510(k) K936198

ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES by Carl Zeiss, Inc. — Product Code GCT

K936198 is an FDA 510(k) premarket notification submitted by Carl Zeiss, Inc. for the device "ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES". The FDA issued a decision of Substantially Equivalent on April 6, 1994. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. Carl Zeiss, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1994
Date Received
December 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Endoscope, Xenon Arc
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Carl Zeiss, Inc.

  • K013402 — VISULAS 532S (November 14, 2001)
  • K003885 — VISULAS YAG II (February 22, 2001)
  • K993357 — IOLMASTER (March 20, 2000)
  • K983868 — OPMI TWINER SURGICAL MICROSCOPE (January 29, 1999)
  • K965139 — SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM (April 23, 1997)
  • K961380 — CPC PROBE (March 17, 1997)
  • K961171 — HUMPHREY OCT SCANNER (June 21, 1996)
  • K954167 — HUMPHREY FIELD ANALYZER (HFA II) (November 24, 1995)
  • K952894 — VISULINK 900 ARGON (August 14, 1995)
  • K950985 — ZEISS ENDOLIVE STERO ENDOSCOPE (March 29, 1995)

Other clearances for product code GCT

  • K093125 — ALPHAXENON LIGHT 180 W AND 300 W (January 27, 2010)
  • K082925 — XENON-100 SCB LIGHT SOURCE, MODEL 20132620 (December 18, 2008)
  • K070376 — CONMED LINVATEC 300W XENON LIGHT SOURCE (August 20, 2007)
  • K040949 — VIADUCT MINISCOPE AND ACCESSORIES (May 7, 2004)
  • K022490 — KSEA MEDI PACK (September 29, 2003)
  • K031994 — LINVATEC 300W XENON LIGHT SOURCE (August 21, 2003)
  • K023468 — ENDOSCOPIC LIGHT SOURCE XL180/L3 (January 14, 2003)
  • K021717 — ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 (August 20, 2002)
  • K020889 — ENDOSCOPIC LIGHT SOURCE XL202/L3 (June 5, 2002)
  • K013880 — DAYLITE XENON LIGHT SOURCES (December 7, 2001)

FDA data resources