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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 K252561
Device Name BTL-754FF
Applicant
BTL Industries, Inc.
362 Elm St.
Malborough,  MA  01752
Applicant Contact Chmel David
Correspondent
BTL Industries, Inc.
362 Elm St.
Malborough,  MA  01752
Correspondent Contact Chmel David
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received08/13/2025
Decision Date 02/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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