FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇮 Slovenia
StarFormer
K Number: K234061
·
Decision Jul 1, 2024
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
95
Applicant Total
16
Review Days
192
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Basic Information
- Device Name
- StarFormer
- K Number
- K234061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5320
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fotona D.O.O.
- Date Received
- December 22, 2023
- Decision Date
- July 1, 2024
- Product Code
- KPI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Fotona D.O.O.
| K Number | Device Name | ||
|---|---|---|---|
| K241785 | StarFormer (M008-3T) | Mar 27, 2025 | Substantially Equivalent |
| K242202 | LightWalker Laser System Family | Aug 23, 2024 | Substantially Equivalent |
| K221274 | StarFormer, TightWave | Sep 29, 2023 | Substantially Equivalent |
| K223540 | AvalancheLase Family | Jan 19, 2023 | Substantially Equivalent |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | Oct 12, 2022 | Substantially Equivalent |
| K213267 | Dynamis Pro Family | Sep 8, 2022 | Substantially Equivalent |
| K202991 | Fotona XPulse Pro Laser Platform | Jun 22, 2021 | Substantially Equivalent |
| K202985 | LightWalker Laser System Family | Mar 19, 2021 | Substantially Equivalent |
| K202172 | StarWalker | Nov 19, 2020 | Substantially Equivalent |
| K193656 | SkyPulse | Mar 27, 2020 | Substantially Equivalent |