Minnesota Laser Corp.: FDA clearances and approvals
Minnesota Laser Corp. has 12 FDA 510(k) clearances (first 1985, latest 1988), across 5 product codes in 5 review panels. Median 510(k) review time: 98 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 | 5 | 5 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 2 | 2 |
| HHR | Laser, Surgical, Gynecologic | 2 | 2 |
| LNK | Laser For Gastro-Urology Use | 2 | 2 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 1 | 1 |
Review panels
- General and Plastic Surgery (5)
- Ear, Nose and Throat (2)
- Gastroenterology and Urology (2)
- Obstetrics and Gynecology (2)
- Anesthesiology (1)
Most recent Minnesota Laser Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874255 | ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. | LNK | 1988-07-12 | 266 |
| K874253 | ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. | LNK | 1988-07-12 | 266 |
| K874254 | ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS | LLO | 1988-03-04 | 136 |
| K854473 | PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC | GEX | 1986-06-20 | 226 |
| K854468 | PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC | GEX | 1986-06-20 | 226 |
| K854471 | PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T | EWG | 1986-02-13 | 99 |
| K854472 | PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG | GEX | 1986-02-11 | 97 |
| K854469 | PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG | GEX | 1986-02-11 | 97 |
| K854470 | PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI | HHR | 1986-02-07 | 93 |
| K852694 | PORTALASE 200 CARBON SURGICAL LASER SYSTEM | HHR | 1985-09-30 | 96 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Minnesota 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 Minnesota Laser Corp. have?
Minnesota Laser Corp. has 12 FDA 510(k) clearances (first 1985, latest 1988), across 5 product codes in 5 review panels.
How long does FDA take to clear Minnesota Laser Corp.'s 510(k)s?
The median time from FDA receipt to decision across Minnesota Laser Corp.'s cleared 510(k)s is 98 days.
What devices does Minnesota Laser Corp. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 5); EWG (Laser, Ent Microsurgical Carbon-Dioxide, 2); HHR (Laser, Surgical, Gynecologic, 2).
Has Minnesota Laser Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Minnesota Laser Corp. Related entities may recall under other names.
Next steps
- See all 12 Minnesota Laser Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Minnesota 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.