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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 K251100
Device Name IPGTFL-02
Applicant
Ipg Medical Corporation
225 Cedar Hill St.
Marlborough,  MA  01752
Applicant Contact Kevin O'Conell
Correspondent
Ipg Medical Corporation
225 Cedar Hill St.
Marlborough,  MA  01752
Correspondent Contact Kevin O'Conell
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/10/2025
Decision Date 09/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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