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510(k) K993300

COLDLIGHTSOURCE PL3000 by Fiber Imaging Technologies, Inc. — Product Code FCW

K993300 is an FDA 510(k) premarket notification submitted by Fiber Imaging Technologies, Inc. for the device "COLDLIGHTSOURCE PL3000". The FDA issued a decision of Substantially Equivalent on November 5, 1999. The device falls under product code FCW (Light Source, Fiberoptic, Routine), a Class II device regulated under 21 CFR 876.1500. Fiber Imaging Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1999
Date Received
October 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Fiber Imaging Technologies, Inc.

  • K992527 — URETERO-RENOSCOPE (October 13, 1999)
  • K992437 — SCHOELLY RIGID ENDOSCOPES (September 14, 1999)
  • K992040 — FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES (August 6, 1999)
  • K991560 — NASO-LARYNGO-PHARYNGOSCOPE (July 13, 1999)

Other clearances for product code FCW

  • K131226 — NOVAPROBE LED LIGHT SOURCE (July 24, 2014)
  • K123956 — POWER LED 175 (January 25, 2013)
  • K123359 — OVS1 VIDEO SYSTEM (December 19, 2012)
  • K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (September 20, 2012)
  • K093792 — LED LIGHT SOURCE (March 18, 2010)
  • K091968 — KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C (September 14, 2009)
  • K082813 — STRYKER LED LIGHTSOURCE (December 19, 2008)
  • K081477 — LUXTEC MLX LIGHT SOURCE (June 18, 2008)
  • K032430 — ACUEITY MEDICAL LIGHT SOURCE (September 5, 2003)
  • K012265 — METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (October 17, 2001)

FDA data resources