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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K262364
Device Name Ellian Enigma RF Device
Applicant
Ellian Corp
1825 E. Plano Pkwy.
Suite 200
Plano,  TX  75074
Applicant Contact Julie Summerville
Correspondent
Ellian Corp
1825 E. Plano Pkwy.
Suite 200
Plano,  TX  75074
Correspondent Contact Julie Summerville
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/10/2026
Decision Date 09/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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