Lasermed, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Lasermed, Inc.” (first 1983, latest 1999), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 102 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 4 | 4 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Lasermed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992061 | PULSTAR | GEX | 1999-07-30 | 42 |
| K970637 | ACCUCURE 1000 | GEX | 1997-04-02 | 41 |
| K964486 | ACCUCURE 3000 | GEX | 1997-02-18 | 102 |
| K943411 | ACCUCURE 3000 | GEX | 1995-04-25 | 285 |
| K843594 | AIRVIT MODEL 8500 | HQE | 1985-04-11 | 211 |
| K833532 | OCULASE 514 OPHTHALMIC ARGON LASER | HQF | 1984-02-04 | 116 |
| K828583 | LASERMED OCULASE ARGON LASER | — | 1983-01-14 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Lasermed, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lasermed, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Lasermed, Inc.” (first 1983, latest 1999), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lasermed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lasermed, Inc. is 102 days.
Which FDA product codes appear under Lasermed, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 4); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 1); HQF (Laser, Ophthalmic, 1).
Next steps
- See all 7 Lasermed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Lasermed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.