Technolas Perfect Vision GmbH: FDA clearances and approvals
Technolas Perfect Vision GmbH has 10 FDA 510(k) clearances (first 1999, latest 2020), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time: 177 days. It is the industry lead sponsor of 7 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 169 |
| 2013 | 1 | 186 |
| 2014 | 2 | 156 |
| 2015 | 2 | 144 |
| 2016 | 0 | — |
| 2017 | 1 | 198 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 166 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Technolas Perfect Vision GmbH's cleared 510(k)s took a median 182 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OOE | Ophthalmic Femtosecond Laser | 9 | 9 |
| LZS | Excimer Laser System | 1 | 0 |
| MXK | Device, Analysis, Anterior Segment | 1 | 1 |
Review panels
- Ophthalmic (11)
Most recent Technolas Perfect Vision GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200724 | VICTUS Femtosecond Laser Platform | OOE | 2020-09-01 | 166 |
| K171014 | VICTUS Femtosecond Laser Platform | OOE | 2017-10-19 | 198 |
| K151161 | VICTUS Femtosecond Laser Platform | OOE | 2015-06-24 | 54 |
| K141379 | VICTUS FEMTOSECOND LASER PLATFORM | OOE | 2015-01-16 | 234 |
| K140615 | VICTUS FEMTOSECOND LASER PLATFORM | OOE | 2014-07-15 | 127 |
| K132534 | VICTUS FEMTOSECOND LASER PLATFORM | OOE | 2014-02-14 | 185 |
| K122386 | VICTUS FEMTOSECOND LASER PLATFORM | OOE | 2013-02-08 | 186 |
| K120426 | VICTUS LASER PLATFORM | OOE | 2012-07-31 | 169 |
| K110427 | FEMTEC LASER SYSTEM FOR CAPSULOTOMY | OOE | 2011-11-22 | 281 |
| K984443 | ORBSCAN | MXK | 1999-03-05 | 81 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990027 | PMA | TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z) | 2000-02-23 |
Recalls
openFDA lists no recalls under a recalling firm named Technolas Perfect Vision GmbH.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Technolas Perfect Vision GmbH is the industry lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02023437: Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery (Completed, started 2013-12)
- NCT01971177: Addressing of Efficacy and Safety of Femtosecond-laser Assisted Versus Manual Lens Fragmentation Procedure (Completed, started 2013-10)
- NCT01885780: Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy. (Completed, started 2013-01)
- NCT01769313: A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery (Completed, started 2013-01)
- NCT01752218: A Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery (Completed, started 2013-01)
Frequently asked questions
How many FDA 510(k) clearances does Technolas Perfect Vision GmbH have?
Technolas Perfect Vision GmbH has 10 FDA 510(k) clearances (first 1999, latest 2020), plus 1 PMA decision, across 3 product codes in 1 review panel.
How long does FDA take to clear Technolas Perfect Vision GmbH's 510(k)s?
The median time from FDA receipt to decision across Technolas Perfect Vision GmbH's cleared 510(k)s is 177 days.
What devices does Technolas Perfect Vision GmbH make?
Its most frequent FDA product codes are OOE (Ophthalmic Femtosecond Laser, 9); LZS (Excimer Laser System, 1); MXK (Device, Analysis, Anterior Segment, 1).
Has Technolas Perfect Vision GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Technolas Perfect Vision GmbH. Related entities may recall under other names.
Next steps
- See all 10 Technolas Perfect Vision GmbH clearances with predicates and recalls
- Run predicate analysis for product code OOE, Technolas Perfect Vision GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.