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510(k) K000229

VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE by Videolabs, Inc. — Product Code FCW

K000229 is an FDA 510(k) premarket notification submitted by Videolabs, Inc. for the device "VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on March 21, 2000. The device falls under product code FCW (Light Source, Fiberoptic, Routine), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2000
Date Received
January 27, 2000
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

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  • 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