Fotona D.O.O.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Fotona D.O.O.” (first 2017, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 114 days. Since 2017 the median was 114 days, against 96 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 94 |
| 2018 | 1 | 90 |
| 2019 | 1 | 79 |
| 2020 | 3 | 88 |
| 2021 | 2 | 218 |
| 2022 | 2 | 232 |
| 2023 | 2 | 285 |
| 2024 | 2 | 110 |
| 2025 | 1 | 280 |
| 2026 | 1 | 387 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fotona D.O.O. took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 14 | 14 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
| QPL | Electromagnetic Stimulator, Pain Relief | 1 | 1 |
Review panels
Most recent Fotona D.O.O. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252723 | Dynamis Pro Family | GEX | 2026-09-19 | 387 |
| K241785 | StarFormer (M008-3T) | QPL | 2025-03-27 | 280 |
| K242202 | LightWalker Laser System Family | GEX | 2024-08-23 | 28 |
| K234061 | StarFormer | KPI | 2024-07-01 | 192 |
| K221274 | StarFormer, TightWave | IPF | 2023-09-29 | 515 |
| K223540 | AvalancheLase Family | GEX | 2023-01-19 | 55 |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | GEX | 2022-10-12 | 121 |
| K213267 | Dynamis Pro Family | GEX | 2022-09-08 | 343 |
| K202991 | Fotona XPulse Pro Laser Platform | GEX | 2021-06-22 | 265 |
| K202985 | LightWalker Laser System Family | GEX | 2021-03-19 | 170 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fotona D.O.O..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Fotona D.O.O. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03676894: Intraurethral/Intravaginal 2940 Nm Erbium Laser Treatment for Stress Urinary Incontinence (Completed, started 2018-06-04)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Fotona D.O.O. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fotona D.D. (27 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fotona D.O.O.?
FDA lists 17 510(k) clearances under the applicant name “Fotona D.O.O.” (first 2017, latest 2026), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fotona D.O.O.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fotona D.O.O. is 114 days. Since 2017: 114 days, versus 96 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fotona D.O.O.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 14); IPF (Stimulator, Muscle, Powered, 1); KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 1).
Next steps
- See all 17 Fotona D.O.O. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Fotona D.O.O.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.