FDA applicant
Technolas Perfect Vision GmbH
FDA records 12 decisions for Technolas Perfect Vision GmbH (Anaheim Hills, CA) from 1999 to 2020: 10 510(k) clearances and 2 original PMA approvals. Most are in product codes OOE (Ophthalmic Femtosecond Laser) and LZS (Excimer Laser System). Its devices cite 26 predicates, 13 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Technolas GmbH Perfect Vision”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Technolas Perfect Vision GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Technolas Perfect Vision GmbH’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) Report