Laseroptek Co., Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Laseroptek Co., Ltd.” (first 2009, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 131 days. Since 2017 the median was 106 days, against 90 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 247 |
| 2017 | 1 | 63 |
| 2018 | 1 | 150 |
| 2019 | 1 | 28 |
| 2020 | 1 | 211 |
| 2021 | 2 | 122 |
| 2022 | 1 | 290 |
| 2023 | 2 | 77 |
| 2024 | 0 | — |
| 2025 | 1 | 60 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Laseroptek Co., Ltd. took a median 106 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 13 | 13 |
Review panels
Most recent Laseroptek Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243780 | HELIOS 785 Pico (1754V2) | GEX | 2025-02-07 | 60 |
| K230373 | HELIOS 785 Pico | GEX | 2023-05-22 | 98 |
| K223588 | PALLAS Premium | GEX | 2023-01-26 | 56 |
| K212663 | HELIOS IV 785 | GEX | 2022-06-09 | 290 |
| K212573 | PicoLO Premium | GEX | 2021-12-08 | 114 |
| K203491 | PicoLO Nd: YAG Picosecond Laser System | GEX | 2021-04-07 | 131 |
| K191501 | PALLAS 308/311 Solid-State UV Laser System | GEX | 2020-01-03 | 211 |
| K183392 | PicoLO Nd:YAG Picosecond Laser System | GEX | 2019-01-04 | 28 |
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser System | GEX | 2018-12-27 | 150 |
| K172639 | PALLAS 308/311 Solid-State UV Laser System | GEX | 2017-11-03 | 63 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Laseroptek Co., Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Laseroptek Co., Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Laseroptek Co., Ltd.” (first 2009, latest 2025), across 1 product code 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 Laseroptek Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laseroptek Co., Ltd. is 131 days. Since 2017: 106 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Laseroptek Co., Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 13).
Next steps
- See all 13 Laseroptek Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Laseroptek Co., Ltd.'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.