Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fotona D.O.O. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
343 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241785 | StarFormer (M008-3T) | Fotona D.O.O. | 2025-03-27 | 280 | 0 |
| K242202 | LightWalker Laser System Family | Fotona D.O.O. | 2024-08-23 | 28 | 0 |
| K234061 | StarFormer | Fotona D.O.O. | 2024-07-01 | 192 | 0 |
| K221274 | StarFormer, TightWave | Fotona D.O.O. | 2023-09-29 | 515 | 0 |
| K223540 | AvalancheLase Family | Fotona D.O.O. | 2023-01-19 | 55 | 0 |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 81 | Fotona D.O.O. | 2022-10-12 | 121 | 0 |
| K213267 | Dynamis Pro Family | Fotona D.O.O. | 2022-09-08 | 343 | 0 |
| K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021-06-22 | 265 | 0 |
| K202985 | LightWalker Laser System Family | Fotona D.O.O. | 2021-03-19 | 170 | 0 |
| K202172 | StarWalker | Fotona D.O.O. | 2020-11-19 | 108 | 0 |
| K193656 | SkyPulse | Fotona D.O.O. | 2020-03-27 | 88 | 0 |
| K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020-03-25 | 86 | 0 |
| K191554 | LightWalker Laser System Family | Fotona D.O.O. | 2019-08-30 | 79 | 0 |
| K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. | 2018-10-31 | 90 | 0 |
| K172819 | LightWalker Laser System Family | Fotona D.O.O. | 2017-12-01 | 74 | 0 |
| K171227 | StarWalker | Fotona D.O.O. | 2017-08-18 | 114 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda