Medical Energy, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Medical Energy, Inc.” (first 1987, latest 2004), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| LNK | Laser For Gastro-Urology Use | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 1 | 1 |
Review panels
Most recent Medical Energy, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041419 | LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM | GEX | 2004-08-26 | 90 |
| K871512 | SL-100 ND:YAG LASER FOR GYNECOLOGY USE | GEX | 1988-07-08 | 445 |
| K871511 | SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | LLO | 1987-07-21 | 92 |
| K871516 | SL-100 ND:YAG LASER FOR UROLOGIC SURGERY | LNK | 1987-07-09 | 80 |
| K871515 | SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING | LNK | 1987-07-09 | 80 |
| K871514 | SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID | LNK | 1987-07-09 | 80 |
| K871513 | SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI | LNK | 1987-07-09 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Energy, 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 Energy, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Medical Energy, Inc.” (first 1987, latest 2004), across 3 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 Energy, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Energy, Inc. is 80 days.
Which FDA product codes appear under Medical Energy, Inc.?
The most frequent FDA product codes under this applicant name are LNK (Laser For Gastro-Urology Use, 4); GEX (Powered Laser Surgical Instrument, 2); LLO (Laser, Neodymium:Yag, Pulmonary Surgery, 1).
Next steps
- See all 7 Medical Energy, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNK, Medical Energy, 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.