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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 K120231
Device Name EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
Original Applicant
BIOLITEC MEDICAL DEVICES, INC
1349 main road
granville,  MA  01034
Original Contact harry hayes, ph.d
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/25/2012
Decision Date 04/24/2012
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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