FDA applicant
Laser-Optik-Systeme GmbH & Co. KG
FDA records 7 decisions for Laser-Optik-Systeme GmbH & Co. KG (Mainz, DE) from 1994 to 1999: 7 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GCT (Light Source, Endoscope, Xenon Arc). No recall is linked to its devices.
FDA’s records also spell it “Laser Optik Systeme GmbH & Co. KG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Laser-Optik-Systeme GmbH & Co. KG’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Laser-Optik-Systeme GmbH & Co. KG since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Laser-Optik-Systeme GmbH & Co. KG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Laser-Optik-Systeme”
FDA records each applicant name separately; these may or may not be the same firm.