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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 K142860
Device Name Lumenis M22 System
Applicant
Lumenis Ltd.
6 Hakidma Street
Yokneam,  IL 20692
Applicant Contact Yoram Levy
Correspondent
Boston Scientific
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Donna M Gardner
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ONF   ONG  
Date Received10/01/2014
Decision Date 01/21/2015
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
Recalls CDRH Recalls
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