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510(k) K032430

ACUEITY MEDICAL LIGHT SOURCE by Acueity, Inc. — Product Code FCW

K032430 is an FDA 510(k) premarket notification submitted by Acueity, Inc. for the device "ACUEITY MEDICAL LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on September 5, 2003. The device falls under product code FCW (Light Source, Fiberoptic, Routine), a Class II device regulated under 21 CFR 876.1500. Acueity, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2003
Date Received
August 6, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Acueity, Inc.

  • K040949 — VIADUCT MINISCOPE AND ACCESSORIES (May 7, 2004)
  • K032847 — EXCISOR BIOPTOME, MODEL 01-0004 (September 26, 2003)
  • K011189 — VIADUCT MICROENDOSCOPE AND ACCESSORIES (July 16, 2001)

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)
  • K012265 — METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (October 17, 2001)
  • K000229 — VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE (March 21, 2000)

FDA data resources