Cleared Traditional

K241785 - StarFormer (M008-3T) (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241785 · Fotona D.O.O. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
280d
Days
Class 2
Risk

K241785 is an FDA 510(k) clearance for the StarFormer (M008-3T). Classified as Electromagnetic Stimulator, Pain Relief (product code QPL), Class II - Special Controls.

Submitted by Fotona D.O.O. (Ljubljana, SI). The FDA issued a Cleared decision on March 27, 2025 after a review of 280 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.5890 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Fotona D.O.O. devices

Submission Details

510(k) Number K241785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2024
Decision Date March 27, 2025
Days to Decision 280 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 115d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QPL Electromagnetic Stimulator, Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - QPL Electromagnetic Stimulator, Pain Relief

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