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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 K241270
Device Name BTL-754
Applicant
BTL Industries, Inc.
362 Elm St.
Malborough,  MA  01752
Applicant Contact David Chmel
Correspondent
BTL Industries, Inc.
362 Elm St.
Malborough,  MA  01752
Correspondent Contact David Chmel
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received05/06/2024
Decision Date 01/30/2025
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
Predetermined Change
Control Plan Authorized		 No
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