Medical Laser, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Medical Laser, Inc.” (first 1989, latest 1991), plus 1 PMA decision, across 8 product codes in 3 review panels. Median 510(k) review time under this name: 112 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 |
|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 2 | 2 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| GCM | Endoscope, Rigid | 1 | 1 |
| GCQ | Endoscope, Flexible | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| LOI | Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary | 1 | 0 |
| LRO | General Surgery Tray | 1 | 1 |
| ODF | Mini Endoscope, Gastroenterology-Urology | 1 | 1 |
Review panels
Most recent Medical Laser, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913136 | LASER ENDOSCOPE DISC DECOMPRESSION KITS | LRO | 1991-11-01 | 108 |
| K912265 | MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 | FED | 1991-10-10 | 141 |
| K912447 | SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 | FET | 1991-09-27 | 116 |
| K912089 | MODIFIED SERIES 2100 ENDOSCOPES | ODF | 1991-08-12 | 91 |
| K901464 | MEDILASE SERIES 2200 ENDOSCOPE | GCM | 1990-08-07 | 132 |
| K900894 | MEDILASE SERIES 2100 ENDOSCOPE | GCQ | 1990-06-22 | 115 |
| K900380 | MEDILASE 5010 ENDOSCOPE CONSOLE | FET | 1990-05-15 | 109 |
| K895837 | MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR | GEX | 1989-12-14 | 72 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P830025 | PMA | MEDITEC OPL3 ND:YAG LASER | 1985-01-14 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Laser, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Laser, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Medical Laser, Inc.” (first 1989, latest 1991), plus 1 PMA decision, across 8 product codes in 3 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 Medical Laser, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Laser, Inc. is 112 days.
Which FDA product codes appear under Medical Laser, Inc.?
The most frequent FDA product codes under this applicant name are FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 2); FED (Endoscopic Access Overtube, Gastroenterology-Urology, 1); GCM (Endoscope, Rigid, 1).
Next steps
- See all 8 Medical Laser, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FET, Medical Laser, 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.