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510(k) K971057

COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM by Cogent Light Technologies, Inc. — Product Code GCT

K971057 is an FDA 510(k) premarket notification submitted by Cogent Light Technologies, Inc. for the device "COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on March 28, 1997. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. Cogent Light Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1997
Date Received
March 24, 1997
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 Cogent Light Technologies, Inc.

  • K001698 — MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 (July 17, 2000)
  • K983714 — SOLARTEC SOURCE 270, MODEL # 90123 (December 23, 1998)
  • K936048 — LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) (March 10, 1994)
  • K933405 — COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE (February 18, 1994)

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