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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 K123177
Device Name STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM
Applicant
Laserstim, Inc.
8708 Capehart Cove
Austin,  TX  78733
Applicant Contact DAVID C FURR
Correspondent
Laserstim, Inc.
8708 Capehart Cove
Austin,  TX  78733
Correspondent Contact DAVID C FURR
Regulation Number890.5500
Classification Product Code
ILY  
Subsequent Product Code
GZJ  
Date Received10/09/2012
Decision Date 07/03/2013
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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