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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 K211534
Device Name RevoLix HTL
Applicant
LISA Laser Products GmbH
Albert-Einstein-Str, 4
Katlenburg-Lindau,  DE 37191
Applicant Contact Ralf Balkenhol
Correspondent
LISA Laser Products GmbH
Albert-Einstein-Str, 4
Katlenburg-Lindau,  DE 37191
Correspondent Contact Ralf Balkenhol
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/18/2021
Decision Date 05/19/2022
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
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