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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered
510(k) Number K221274
Device Name StarFormer, TightWave
Applicant
Fotona d.o.o.
Stegne 7
Ljubljana,  SI 1000
Applicant Contact Tina Bartolic
Correspondent
Fotona d.o.o.
Stegne 7
Ljubljana,  SI 1000
Correspondent Contact Tina Bartolic
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
NGX  
Date Received05/02/2022
Decision Date 09/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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