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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 K211979
Device Name Lumenis Y&R Laser System
Applicant
Lumenis Inc.
1870 S Milestone Dr
Salt Lake City,  UT  84104
Applicant Contact Karen Smith
Correspondent
Kathy Maynor
26 Rebecca Ct
Homosassa,  FL  34446
Correspondent Contact Kathy Maynor
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received06/25/2021
Decision Date 06/21/2022
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
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