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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 K151473
Device Name NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module
Applicant
FOCUS MEDICAL, LLC.
23 FRANCIS J CLARKE CIRCLE
bethel,  CT  06801
Applicant Contact john b lee
Correspondent
MMP MEDICAL ASSOCIATES LLC
16 APPLETON ST
waltham,  MA  02453
Correspondent Contact michail m pankratov
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/01/2015
Decision Date 09/01/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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