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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 K260255
Device Name AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)
Applicant
Aventix Medical, Inc.
23282 Mill Creek Dr.
Suite 350
Laguna Hills,  CA  92653
Applicant Contact Jetmir Palushi
Correspondent
Albatross Regulatory Consulting
25606 Corte Botella
Murrieta,  CA  92563
Correspondent Contact David Locke
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/28/2026
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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