Data / Medical devices / Excimer Laser System
Excimer Laser System (LZS): 11 FDA-registered makers in 3 countries
11 establishments in 3 countries are registered with the FDA to make Excimer Laser System (product code LZS, Class 3). 11 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 14 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LZS
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| Germany | 5 |
| United States | 4 |
| Japan | 2 |
Makers of Excimer Laser System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| WAVELIGHT GmbH | ERLANGEN Bavaria, Germany | Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| WAVELIGHT GmbH | PRESSATH Bavaria, Germany | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| AMO Manufacturing USA, LLC | Milpitas, CA, United States | Manufacturer, Specification developer | 0 | 1 | 5 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Saint Louis, MO, United States | Remanufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Meditec AG (jena) | JENA Thuringia, Germany | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Meditec AG (Jena) | Jena Thuringia, Germany | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Nidek Co., Ltd. | Gamagori, Aichi, Japan | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Nidek Co., Ltd. Hamacho Plant | Gamagori, Aichi, Japan | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Nidek Incorporated | The Colony, TX, United States | Manufacturer | 0 | 1 | 3 | 0 | api.fda.gov | |
| Technolas Perfect Vision GMBH | Munchen Bavaria, Germany | Exporter to the US, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.