Lasermatic, Inc.: FDA clearances and approvals
Lasermatic, Inc. has 8 FDA 510(k) clearances (first 1988, latest 1991), across 4 product codes in 4 review panels. Median 510(k) review time: 250 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 | 4 | 4 |
| LNK | Laser For Gastro-Urology Use | 2 | 2 |
| HHR | Laser, Surgical, Gynecologic | 1 | 1 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 1 | 1 |
Review panels
- General and Plastic Surgery (4)
- Gastroenterology and Urology (2)
- Anesthesiology (1)
- Obstetrics and Gynecology (1)
Most recent Lasermatic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903131 | LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM | GEX | 1991-02-19 | 217 |
| K901638 | MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 | GEX | 1990-06-27 | 79 |
| K893529 | COMBOLASER MODEL 5050 | GEX | 1989-06-08 | 31 |
| K871875 | MODEL 5050 SURGILASER FOR OB-GYN USE | HHR | 1988-08-22 | 466 |
| K871934 | MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE | LNK | 1988-03-25 | 311 |
| K871932 | MODEL 5050 SURGILASER FOR UROLOGY USE | LNK | 1988-03-25 | 311 |
| K871933 | MODEL 5050 SURGILASER FOR NEUROSURGERY USE | GEX | 1988-01-22 | 248 |
| K871876 | MODEL 5050 SURGILASER FOR PULMONARY USE | LLO | 1988-01-22 | 253 |
Recalls
openFDA lists no recalls under a recalling firm named Lasermatic, 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 Lasermatic, Inc. have?
Lasermatic, Inc. has 8 FDA 510(k) clearances (first 1988, latest 1991), across 4 product codes in 4 review panels.
How long does FDA take to clear Lasermatic, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lasermatic, Inc.'s cleared 510(k)s is 250 days.
What devices does Lasermatic, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 4); LNK (Laser For Gastro-Urology Use, 2); HHR (Laser, Surgical, Gynecologic, 1).
Has Lasermatic, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lasermatic, Inc. Related entities may recall under other names.
Next steps
- See all 8 Lasermatic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Lasermatic, 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.