American Laser Corp.: FDA clearances and approvals
American Laser Corp. has 5 FDA 510(k) clearances (first 1982, latest 2001), across 4 product codes in 2 review panels. Median 510(k) review time: 76 days.
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 | 2 | 2 |
| HPJ | Instrument, Visual Field, Laser | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent American Laser Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010046 | NUVOLASE 532 MEDICAL LASER SYSTEM | GEX | 2001-04-05 | 90 |
| K990665 | BQ/BM INTEGRATED LASER DELIVERY SYSTEM | HQF | 1999-05-17 | 76 |
| K990725 | NUVOLASE 532 LASER SYSTEM | GEX | 1999-03-22 | 17 |
| K827819 | LASER PHOTOCOAGULATOR | — | 1983-01-07 | 80 |
| K813429 | LASER PHOTOCOAGULATOR ARGON MED. LASER | HPJ | 1982-01-22 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named American Laser Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances does American Laser Corp. have?
American Laser Corp. has 5 FDA 510(k) clearances (first 1982, latest 2001), across 4 product codes in 2 review panels.
How long does FDA take to clear American Laser Corp.'s 510(k)s?
The median time from FDA receipt to decision across American Laser Corp.'s cleared 510(k)s is 76 days.
What devices does American Laser Corp. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 2); HPJ (Instrument, Visual Field, Laser, 1); HQF (Laser, Ophthalmic, 1).
Has American Laser Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching American Laser Corp. Related entities may recall under other names.
Next steps
- See all 5 American Laser Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEX, American Laser Corp.'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.