Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laser Optik Systeme GmbH & Co. KG · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
455 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992540 | XENON LIGHT SOURCE PES 1 | Laser Optik Systeme GmbH & Co. KG | 1999-09-14 | 47 | 0 |
| K972056 | STANDARD ENDOSCOPE | Laser-Optik-Systeme GmbH & Co. KG | 1997-07-30 | 58 | 0 |
| K950712 | PORTABLE ENDOSCOPY SYSTEM | Laser-Optik-Systeme GmbH & Co. KG | 1996-05-14 | 455 | 0 |
| K953419 | LOS 3D VISION 100 | Laser Optik Systeme GmbH & Co. KG | 1996-02-08 | 220 | 0 |
| K952028 | COLD LIGHT SOURCE LOS XL-A 100 | Laser-Optik-Systeme GmbH & Co. KG | 1995-07-27 | 87 | 0 |
| K951829 | COLD LIGHT SOURCE LOS 150 | Laser-Optik-Systeme GmbH & Co. KG | 1995-07-10 | 81 | 0 |
| K930965 | LOS 3D VISION 100 | Laser Optik Systeme GmbH & Co. KG | 1994-04-11 | 411 | 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