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510(k) K983714

SOLARTEC SOURCE 270, MODEL # 90123 by Cogent Light Technologies, Inc. — Product Code FFS

K983714 is an FDA 510(k) premarket notification submitted by Cogent Light Technologies, Inc. for the device "SOLARTEC SOURCE 270, MODEL # 90123". The FDA issued a decision of Substantially Equivalent on December 23, 1998. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), 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
December 23, 1998
Date Received
October 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image, Illumination, Fiberoptic, For Endoscope
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)
  • K971057 — COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM (March 28, 1997)
  • 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 FFS

  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
  • K061622 — PS SERIES (March 5, 2007)
  • K063309 — TRU-CABLE (January 12, 2007)
  • K061025 — ACCUTECH ENDOLITE PROBE (May 31, 2006)
  • K023633 — SOVIS OPTIQUE'S ENDOSCOPIC CABLE (December 31, 2002)
  • K001698 — MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 (July 17, 2000)
  • K994084 — SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES (January 20, 2000)
  • K991323 — SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR (July 6, 1999)
  • K982462 — FIBER OPTIC ENDOILLUMINATION PROBE (September 14, 1998)
  • K980636 — FIBER OPTIC ENDOILLUMINATION PROBE (May 20, 1998)

FDA data resources