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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lamp, infrared, therapeutic heating
510(k) Number K122125
Model M077XX
Device Name ASA LASER SH1
Original Applicant
17 via baldanzese
calenzano,  IT 50041
Original Contact paolo peruzzi
Regulation Number890.5500
Classification Product Code
Date Received07/18/2012
Decision Date 01/25/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No