StarFormer
FDA 510(k) K234061 · Fotona D.O.O.
510(k) numberK234061
Submission
- Device name
- StarFormer
- Applicant
- Fotona D.O.O.
Ljubljana, SI - Received
- December 22, 2023
- Decision date
- July 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KPI – Stimulator, Electrical, Non-Implantable, For Incontinence
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5320
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KPI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260178 | Pelvic Muscle Trainer (KM510, KM516B)KPI · Traditional | Shenzhen Konmed Technology Co., Ltd. | 06/18/2026SE |
| K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…KPI · Traditional | Hunan Accurate Bio-Medical Technology Co., Ltd. | 05/14/2026SE |
| K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)KPI · Traditional | Shenzhen Changkun Technology Co., Ltd. | 05/06/2026SE |
| K252831 | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924…KPI · Traditional | Dolanvy (Suzhou) Medical Technology Co., Ltd. | 04/28/2026SE |
| K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)KPI · Traditional | Pontemedag | 04/17/2026SE |
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P))KPI · Traditional | Well-Life Healthcare , Ltd. | 02/12/2026SE |
| K251026 | Regenesis EMS ChairKPI · Traditional | Trinity Medical Solutions | 08/29/2025SE |
| K243079 | NeuroTrac® MyoPlus Pro (MYO120U)KPI · Traditional | Verity Medical , Ltd. | 06/26/2025SE |
| K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48)KPI · Traditional | Zmi Electronics , Ltd. | 03/27/2025SE |
| K241516 | BTL-398KPI · Traditional | BTL Industries, Inc. | 02/10/2025SE |
More from BTL Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241785 | StarFormer (M008-3T)QPL · Traditional | 03/27/2025SE |
| K242202 | LightWalker Laser System FamilyGEX · Special | 08/23/2024SE |
| K221274 | StarFormer, TightWaveIPF · Traditional | 09/29/2023SE |
| K223540 | AvalancheLase FamilyGEX · Traditional | 01/19/2023SE |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)GEX · Traditional | 10/12/2022SE |
| K213267 | Dynamis Pro FamilyGEX · Traditional | 09/08/2022SE |
| K202991 | Fotona XPulse Pro Laser PlatformGEX · Traditional | 06/22/2021SE |
| K202985 | LightWalker Laser System FamilyGEX · Traditional | 03/19/2021SE |
| K202172 | StarWalkerGEX · Traditional | 11/19/2020SE |
| K193656 | SkyPulseGEX · Traditional | 03/27/2020SE |
Questions and answers
When was StarFormer cleared by the FDA?
StarFormer (K234061) received a 510(k) decision of Substantially Equivalent on July 1, 2024, 192 days after the submission was received.
What is the product code of K234061?
The FDA product code is KPI – Stimulator, Electrical, Non-Implantable, For Incontinence, a Class II (moderate risk) device regulated under 21 CFR 876.5320.