Laser Photonics, Inc.: FDA clearances and approvals
Laser Photonics, Inc. has 14 FDA 510(k) clearances (first 1988, latest 1994), across 1 product code in 1 review panel. Median 510(k) review time: 148 days. It files with the SEC as Laser Photonics Corp (LASE).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 | 14 | 14 |
Review panels
Most recent Laser Photonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934501 | LASER PHOTONICS ML755 DERMABLASER | GEX | 1994-08-30 | 350 |
| K933140 | RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEM | GEX | 1994-03-02 | 247 |
| K924537 | LPI ML210 HOLMIUM SURGICAL LASER | GEX | 1993-04-07 | 215 |
| K920334 | LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH. | GEX | 1993-03-31 | 429 |
| K915631 | LPI ML 100/532 AND ML 532 SURGICAL LASER | GEX | 1992-06-15 | 181 |
| K914827 | LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION | GEX | 1992-03-27 | 157 |
| K904841 | LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED | GEX | 1991-04-19 | 177 |
| K910233 | LASER PHOTONICS ML-210 HOLMIUM:YAG MEDI LASE SYST | GEX | 1991-04-12 | 84 |
| K904354 | LPI MULILASE YAG/532 SURGICAL LASER SYSTEM | GEX | 1990-12-19 | 86 |
| K904331 | L.P.I. LASER DELIVERY SYSTEM | GEX | 1990-12-17 | 87 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Laser Photonics, Inc..
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.
SEC filings
Laser Photonics Corp (LASE): EDGAR filings, CIK 1807887. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Laser Photonics, Inc. have?
Laser Photonics, Inc. has 14 FDA 510(k) clearances (first 1988, latest 1994), across 1 product code in 1 review panel.
How long does FDA take to clear Laser Photonics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Laser Photonics, Inc.'s cleared 510(k)s is 148 days.
What devices does Laser Photonics, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 14).
Has Laser Photonics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Laser Photonics, Inc. Related entities may recall under other names.
Next steps
- See all 14 Laser Photonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Laser Photonics, Inc.'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.