Data / Medical devices / Germany / WAVELIGHT GmbH
WAVELIGHT GmbH: FDA-registered device maker in ERLANGEN Bavaria, Germany, 2 510(k) clearances and 2 PMA approvals
WAVELIGHT GmbH is registered with the FDA (registration 9710340) in ERLANGEN Bavaria, Germany. It lists 7 device types. The FDA files 2 510(k) clearances and 2 PMA approvals under its listings, the newest dated March 26, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710340
- FEI number
- 3002483854
- Address
- Am Wolfsmantel 5, ERLANGEN Bavaria, Germany, 91058
- Owner or operator
- Alcon Laboratories, Inc. (1610287)
- Roles
- Specification developer
- First device listed
- February 3, 2004
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aberrometer, Ophthalmic | NCF | 1 | Specification developer | accessdata.fda.gov |
| Excimer Laser System | LZS | 3 | Specification developer | accessdata.fda.gov |
| Keratome, Ac-Powered | HNO | 1 | Specification developer | accessdata.fda.gov |
| Ophthalmic Femtosecond Laser | OOE | 2 | Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Specification developer | accessdata.fda.gov |
| Table, Instrument, Powered, Ophthalmic | HRJ | 1 | Specification developer | accessdata.fda.gov |
| Topographer, Corneal, Ac-Powered | MMQ | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 26, 2019 | K190392 | WaveLight FS200 Patient Interface | GEX | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| September 30, 2014 | K141476 | WAVELIGHT FS200 LASER SYSTEM | OOE | Substantially Equivalent | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 10, 2003 | P030008 | WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM | LZS | 38 | January 16, 2025 | accessdata.fda.gov |
| October 7, 2003 | P020050 | WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM | LZS | 43 | March 5, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Table, Instrument, Powered, Ophthalmic
- All makers of Excimer Laser System
- All makers of Topographer, Corneal, Ac-Powered
- All makers of Powered Laser Surgical Instrument
- All makers of Keratome, Ac-Powered
- All makers of Aberrometer, Ophthalmic
Updated January 16, 2025. 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.