Fotona D.D.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Fotona D.D.” (first 1998, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 108 days. 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 |
|---|---|---|
| 2012 | 2 | 154 |
| 2013 | 0 | — |
| 2014 | 1 | 308 |
| 2015 | 1 | 101 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 25 | 25 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 2 | 2 |
Review panels
Most recent Fotona D.D. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | GEX | 2015-04-09 | 101 |
| K132806 | FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE | GEX | 2014-07-11 | 308 |
| K121508 | LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N | PDZ | 2012-12-12 | 205 |
| K113702 | FOTONA XP ND: YAG LASER SYSTEM | PDZ | 2012-03-28 | 103 |
| K101306 | SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A | GEX | 2011-07-01 | 417 |
| K101817 | LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N | GEX | 2010-11-22 | 145 |
| K093162 | FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID | GEX | 2010-01-22 | 108 |
| K090126 | FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, | GEX | 2009-06-29 | 159 |
| K083889 | FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY | GEX | 2009-04-23 | 115 |
| K083034 | FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F | GEX | 2009-02-04 | 117 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fotona D.D..
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.
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.O.O. (17 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fotona D.D.?
FDA lists 27 510(k) clearances under the applicant name “Fotona D.D.” (first 1998, latest 2015), across 2 product codes in 1 review panel. 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.D.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fotona D.D. is 108 days.
Which FDA product codes appear under Fotona D.D.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 25); PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis, 2).
Next steps
- See all 27 Fotona D.D. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Fotona D.D.'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.