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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 K152461
Device Name The Time Machine Series Lasers
Applicant
Medical Lasers Manufacturer, Inc.
4400 Rte. 9 S., Suite 1000
Freehold,  NJ  07728
Applicant Contact BRUCE SCHOENGOOD
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Jigar Shah
Regulation Number890.5500
Classification Product Code
ILY  
Date Received08/28/2015
Decision Date 07/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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