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510(k) K091829

PLS PORTABLE LIGHT SOURCE by Optim, Inc. — Product Code NTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2009
Date Received
June 19, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Led Light Source
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals

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  • K080622 — ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 (April 2, 2008)

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  • K130819 — CLL- V1 LIGHT SOURCE (June 19, 2013)
  • K122831 — VIDEO SYSTEM CENTER (December 14, 2012)
  • K113679 — LUCEA LED SURGICAL LIGHT SYSTEM (January 12, 2012)
  • K103813 — SOPRO 281 (March 22, 2011)
  • K102167 — LO-50 LED LIGHT SOURCE (August 17, 2010)
  • K090601 — FSC 2 (May 11, 2009)