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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered laser surgical instrument
510(k) Number K120235
Device Name MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP
Original Applicant
AEROLASE MEDICAL LASERS LLC
555 thirteenth street
washington,  DC  20004
Original Contact jennifer a henderson
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/25/2012
Decision Date 09/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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