FDA 510(k) Application Details - K032991

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K032991
Device Name Powered Laser Surgical Instrument
Applicant LIGHT AGE, INC.
500 APGAR DRIVE
SOMERSET, NJ 08873-1150 US
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Contact THOMAS C HAUCK
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 09/25/2003
Decision Date 09/14/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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