Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laser Engineering, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
247 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211605 | Dual Switch | Laser Engineering, Inc. | 2022-09-22 | 485 | 0 |
| K141908 | DUAL SWITCH | Laser Engineering, Inc. | 2014-10-22 | 99 | 0 |
| K924457 | MICROMANIPULATOR | Laser Engineering, Inc. | 1993-05-07 | 247 | 0 |
| K912247 | UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY | Laser Engineering, Inc. | 1991-11-13 | 176 | 0 |
| K912347 | BIPURE 1000 | Laser Engineering, Inc. | 1991-09-23 | 118 | 0 |
| K910062 | 02-10,001 | Laser Engineering, Inc. | 1991-08-16 | 219 | 0 |
| K911852 | COMPULSE CO2 SURGICAL LASER SYS. | Laser Engineering, Inc. | 1991-06-07 | 42 | 0 |
| K905676 | MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH | Laser Engineering, Inc. | 1991-04-22 | 125 | 0 |
| K875314 | GL-35 COLPOSCOPIC LASER SYSTEM | Laser Engineering, Inc. | 1988-08-05 | 220 | 0 |
| K881583 | MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT | Laser Engineering, Inc. | 1988-06-03 | 53 | 0 |
| K881586 | MODEL MD-45 CO2 LASER FOR ENT APPLICATIONS | Laser Engineering, Inc. | 1988-06-03 | 53 | 0 |
| K881588 | MODEL MD-25 LASER FOR SURGICAL USE | Laser Engineering, Inc. | 1988-06-03 | 53 | 0 |
| K881584 | MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE | Laser Engineering, Inc. | 1988-06-03 | 53 | 0 |
| K881580 | MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY | Laser Engineering, Inc. | 1988-06-03 | 53 | 0 |
| K881581 | MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE | Laser Engineering, Inc. | 1988-06-03 | 53 | 0 |
| K881585 | MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE | Laser Engineering, Inc. | 1988-06-03 | 53 | 0 |
| K881582 | MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE | Laser Engineering, Inc. | 1988-06-03 | 53 | 0 |
| K881587 | MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS | Laser Engineering, Inc. | 1988-06-03 | 53 | 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