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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 K250809
Device Name Stellar M22
Applicant
Lumenis Be, Ltd.
9 Hakidma St. P.O. Box 426, Yokneam Industrial Park
Yokneam,  IL 2069236
Applicant Contact Shlomit Segman
Correspondent
Lumenis Be, Ltd.
9 Hakidma St. P.O. Box 426, Yokneam Industrial Park
Yokneam,  IL 2069236
Correspondent Contact Shlomit Segman
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ONF   ONG  
Date Received03/17/2025
Decision Date 04/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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