K221274 - StarFormer, TightWave (FDA 510(k) Clearance)

K221274 is an FDA 510(k) clearance for the StarFormer, TightWave. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Fotona D.O.O. (Ljubljana, SI). The FDA issued a Cleared decision on September 29, 2023 after a review of 515 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

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