Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Energy, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
445 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041419 | LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM | Medical Energy, Inc. | 2004-08-26 | 90 | 0 |
| K871512 | SL-100 ND:YAG LASER FOR GYNECOLOGY USE | Medical Energy, Inc. | 1988-07-08 | 445 | 0 |
| K871511 | SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | Medical Energy, Inc. | 1987-07-21 | 92 | 0 |
| K871513 | SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI | Medical Energy, Inc. | 1987-07-09 | 80 | 0 |
| K871516 | SL-100 ND:YAG LASER FOR UROLOGIC SURGERY | Medical Energy, Inc. | 1987-07-09 | 80 | 0 |
| K871515 | SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING | Medical Energy, Inc. | 1987-07-09 | 80 | 0 |
| K871514 | SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID | Medical Energy, Inc. | 1987-07-09 | 80 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda