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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 K091675
Device Name LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER
Applicant
Reimers and Janssen GmbH
Lessingstr. 79
Berlin,  DE 13158
Applicant Contact ASTRID SCHULZE
Correspondent
Reimers and Janssen GmbH
Lessingstr. 79
Berlin,  DE 13158
Correspondent Contact ASTRID SCHULZE
Regulation Number890.5500
Classification Product Code
ILY  
Date Received06/09/2009
Decision Date 12/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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