EMS Swiss LithoClast Trilogy Handpiece Company Statement

To whom it may concern, Object: Sterilization of EMS Swiss LithoClast® Trilogy handpiece

Nyon, the 16th of June 2020 Dear Sir / Madam,

EMS Electro Medical Systems S.A. hereby declares that the Swiss LithoClast Trilogy handpiece has been cleared by the FDA for sterilization with the following H2O2 gas sterilization process: -

STANDARD Cycle of the STERRAD® NX and 100NX,

-

SHORT Cycle of the STERRAD® 100S,

-

LUMEN Cycle of the AMSCO® V-PRO®1, V-PRO®1 Plus, V-PRO® 60, VPRO® maX and V-PRO® maX 2.

The related 510(k) are K181364 and K182490. Best regards, E.M.S. ELECTRO MEDICAL SYSTEMS S.A.

Jerome Blondeau Marketing Manager, Urology

Timothée Deblock Head of Quality

EMS ELECTRO MEDICAL SYSTEMS SA CH. DE LA VUARPILLIERE 31 – CH-1260 – SWITZERLAND – TEL 022 99 44 700 – FAX 022 99 44 701