Cleared Traditional

StarFormer (K234061) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K234061 · Fotona D.O.O. · Gastroenterology & Urology device
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Jul 2024
Decision
192d
Days
Class 2
Risk

K234061 is an FDA 510(k) clearance for the StarFormer. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Fotona D.O.O. (Ljubljana, SI). The FDA issued a Cleared decision on July 1, 2024 after a review of 192 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fotona D.O.O. devices

Submission Details

510(k) Number K234061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2023
Decision Date July 01, 2024
Days to Decision 192 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 130d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 27
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K234061.
Levina Pelvic Floor Muscle Stimulator (RS-48)
K241862 · Zmi Electronics , Ltd. · Mar 2025
BTL-398
K241516 · BTL Industries, Inc. · Feb 2025
Pelvic Floor Stimulator (Intrelief PFE)
K241899 · Easymed Instruments Co., Ltd. · Nov 2024
Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013
K233576 · Shenzhen Konmed Technology Co., Ltd. · Feb 2024
Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
K231166 · Zmi Electronics , Ltd. · Jan 2024
Unicare (K-UNICARE-USA)
K230983 · Tenscare, Ltd. · Oct 2023