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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K261361
Device Name TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet)
Applicant
Carl Zeiss Meditec, AG
Rudolf-Eber-Strasse 11
Oberkochen,  DE 73447
Applicant Contact Anke Seitz
Correspondent
Carl Zeiss Meditec, Inc.
5300 Central Pkwy.
Dublin,  CA  94568
Correspondent Contact Aditya Rao
Classification Product Code
LFL  
Date Received04/27/2026
Decision Date 10/15/2026
Decision Substantially Equivalent (SESE)
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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