FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇮 Slovenia
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
K Number: K221712
·
Decision Oct 12, 2022
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
16
Review Days
121
Basic Information
- Device Name
- Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
- K Number
- K221712
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fotona d.o.o.
- Date Received
- June 13, 2022
- Decision Date
- October 12, 2022
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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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 |
| K234061 | StarFormer | Jul 1, 2024 | Substantially Equivalent |
| K221274 | StarFormer, TightWave | Sep 29, 2023 | Substantially Equivalent |
| K223540 | AvalancheLase Family | Jan 19, 2023 | 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 |