FDA applicant

Wavelight Laser Technologie AG

Erlangen, DE8 decisions2004–20060 recalls

FDA records 8 decisions for Wavelight Laser Technologie AG (Erlangen, DE) from 2004 to 2006: 8 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 36 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Wavelight Laser Technologie AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wavelight Laser Technologie AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wavelight Laser Technologie AG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wavelight Laser Technologie AG’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

Other applicant names beginning “Wavelight”

FDA records each applicant name separately; these may or may not be the same firm.

Wavelight AG 1

Wavelight Laser Technologie AG

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Wavelight”