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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K130195
Device Name SCANNING LASERLINK
Applicant
LUMENIS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact JACE R MCLANE
Correspondent
Boston Scientific
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Donna M Gardner
Regulation Number886.4390
Classification Product Code
HQF  
Date Received01/28/2013
Decision Date 11/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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