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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 K121363
Device Name DIOWAVE LOW LEVEL COLD LASER SYSTEM
Original Applicant
TECHNOLOGICAL MEDICAL ADVANCMENTS, INC. (TMA)
1209 north flagler drive
west palm beach,  FL  33401
Original Contact bruce coren
Regulation Number890.5500
Classification Product Code
ILY  
Date Received05/07/2012
Decision Date 11/23/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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