American Surgical Laser, Inc.: FDA clearances and approvals
American Surgical Laser, Inc. has 5 FDA 510(k) clearances (first 1984, latest 1985), across 3 product codes in 3 review panels. Median 510(k) review time: 93 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 |
|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | 3 | 3 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 1 | 1 |
| HHR | Laser, Surgical, Gynecologic | 1 | 1 |
Review panels
Most recent American Surgical Laser, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843515 | MINUTEMAN CO2 MICROSURGICAL LASER GYN | HHR | 1985-02-04 | 152 |
| K843519 | MINUTEMAN CO2 MICROSURG LASER GEN SURG | GEY | 1984-12-07 | 93 |
| K843518 | MINUTEMAN C02 MICROSURG LASER PODIATRY | GEY | 1984-12-07 | 93 |
| K843517 | MINUTEMAN CO2 MICROSURG LASER DERMATOL- | GEY | 1984-12-07 | 93 |
| K843514 | MINUTEMAN CO2 MICROSURGICAL LASER OTO | EWG | 1984-12-04 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named American Surgical Laser, 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.
Frequently asked questions
How many FDA 510(k) clearances does American Surgical Laser, Inc. have?
American Surgical Laser, Inc. has 5 FDA 510(k) clearances (first 1984, latest 1985), across 3 product codes in 3 review panels.
How long does FDA take to clear American Surgical Laser, Inc.'s 510(k)s?
The median time from FDA receipt to decision across American Surgical Laser, Inc.'s cleared 510(k)s is 93 days.
What devices does American Surgical Laser, Inc. make?
Its most frequent FDA product codes are GEY (Motor, Surgical Instrument, Ac-Powered, 3); EWG (Laser, Ent Microsurgical Carbon-Dioxide, 1); HHR (Laser, Surgical, Gynecologic, 1).
Has American Surgical Laser, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching American Surgical Laser, Inc. Related entities may recall under other names.
Next steps
- See all 5 American Surgical Laser, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEY, American Surgical Laser, 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.