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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K241733
Device Name HEBE (NP0000763)
Applicant
Novasonix Technology S.L.
C/ Pla De Ramasar 52, Pol. Ind, Carrer Pla Del Ramassar
Granollers,  ES 08402
Applicant Contact Carlos Navarro
Correspondent
Freyr, Inc.
150 College Rd. W, #102
Princeton,  NJ  08540
Correspondent Contact Shilpa Gampa
Regulation Number878.4400
Classification Product Code
PBX  
Date Received06/17/2024
Decision Date 04/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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