Topcon Medical Laser Systems, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Topcon Medical Laser Systems, Inc.” (first 2005, latest 2018), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 106 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 | 0 | — |
| 2013 | 1 | 177 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 189 |
| 2018 | 1 | 100 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Topcon Medical Laser Systems, Inc. took a median 144 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQF | Laser, Ophthalmic | 5 | 5 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
Review panels
Most recent Topcon Medical Laser Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | HQF | 2018-05-25 | 100 |
| K171488 | PSLT for PASCAL Streamline | HQF | 2017-11-27 | 189 |
| K123542 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER | HQF | 2013-05-15 | 177 |
| K111108 | PASCAL STREAMLINE 577 (WITH ACCESSORIES) | HQF | 2011-08-11 | 113 |
| K092621 | PASCAL STREAMLINE PHOTOCOAGULATOR | HQF | 2009-09-25 | 30 |
| K043486 | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 | GEX | 2005-03-03 | 76 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2016-07-15.
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.
- Topcon Corporation (23 510(k)s)
- Topcon Medical Systems, Inc. (11 510(k)s)
- Topcon Healthcare Solutions (2 510(k)s)
- Topcon Healthcare Solutions EMEA Oy (2 510(k)s)
- Topcon Medical Laser Systems, Inc. (Tmls) (2 510(k)s)
- Topcon Instrument Corporation of America (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Topcon Medical Laser Systems, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Topcon Medical Laser Systems, Inc.” (first 2005, latest 2018), across 2 product codes in 2 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 Topcon Medical Laser Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Topcon Medical Laser Systems, Inc. is 106 days.
Which FDA product codes appear under Topcon Medical Laser Systems, Inc.?
The most frequent FDA product codes under this applicant name are HQF (Laser, Ophthalmic, 5); GEX (Powered Laser Surgical Instrument, 1).
Next steps
- See all 6 Topcon Medical Laser Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQF, Topcon Medical Laser Systems, Inc.'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.