Cleared Traditional

StarFormer, TightWave

K221274 · Fotona D.O.O. · Physical Medicine
Sep 2023
Decision
515d
Days
Class 2
Risk

About This 510(k) Submission

K221274 is an FDA 510(k) clearance for the StarFormer, TightWave, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Fotona D.O.O. (Ljubljana, SI). The FDA issued a Cleared decision on September 29, 2023, 515 days after receiving the submission on May 2, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K221274 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2022
Decision Date September 29, 2023
Days to Decision 515 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850