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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K202915
Device Name IRIS Thermocoagulator and Digital Colposcope
Applicant
Liger Medical, LLC
3300 N. Running Creek Way, Bldg. G, Suite G20
Lehi,  UT  84043
Applicant Contact Wm. Dean Wallace
Correspondent
Liger Medical, LLC
3300 N. Running Creek Way, Bldg. G, Suite G20
Lehi,  UT  84043
Correspondent Contact Wm. Dean Wallace
Regulation Number884.4120
Classification Product Code
HGI  
Subsequent Product Code
PTZ  
Date Received09/29/2020
Decision Date 04/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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