Mnlase, Inc.: FDA clearances and approvals
Mnlase, Inc. has 22 FDA 510(k) clearances (first 1992, latest 1994), across 3 product codes in 3 review panels. Median 510(k) review time: 44 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 | 17 | 17 |
| JRM | Freezer | 4 | 4 |
| LHC | Warmer, Irrigation Solution | 1 | 1 |
Review panels
Most recent Mnlase, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944630 | MODEL 230-SAS LASER DELIVERY PROBE | GEX | 1994-11-09 | 50 |
| K944629 | MODEL 230-SAC LASER DELIVERY PROBE | GEX | 1994-11-03 | 44 |
| K944628 | MODEL 220-SS LASER DELIVERY PROBE | GEX | 1994-11-03 | 44 |
| K944627 | MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER | GEX | 1994-11-03 | 44 |
| K944626 | MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER | GEX | 1994-11-03 | 44 |
| K944625 | MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER | GEX | 1994-11-03 | 44 |
| K944471 | STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE | GEX | 1994-11-03 | 55 |
| K944470 | CURVED ENDOPHOTOCOAGULATOR LASER PROBE | GEX | 1994-11-03 | 55 |
| K944632 | MODEL 120-SS LASER DELIVERY PROBE | GEX | 1994-11-01 | 42 |
| K944631 | MODEL 120-SC LASER DELIVERY PROBE | GEX | 1994-11-01 | 42 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mnlase, 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 Mnlase, Inc. have?
Mnlase, Inc. has 22 FDA 510(k) clearances (first 1992, latest 1994), across 3 product codes in 3 review panels.
How long does FDA take to clear Mnlase, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mnlase, Inc.'s cleared 510(k)s is 44 days.
What devices does Mnlase, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 17); JRM (Freezer, 4); LHC (Warmer, Irrigation Solution, 1).
Has Mnlase, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mnlase, Inc. Related entities may recall under other names.
Next steps
- See all 22 Mnlase, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Mnlase, 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.