Data / Medical devices / Italy / Luxottica Group S.P.A
Luxottica Group S.P.A: FDA-registered device maker in Milan Milano, Italy, 1 510(k) clearance
Luxottica Group S.P.A is registered with the FDA (registration 3011016506) in Milan Milano, Italy. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 31, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011016506
- Address
- Piazzale Cadorna, 3, Milan Milano, Italy, 20123
- Owner or operator
- Luxottica (10047811)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- November 4, 2014
- Registered through
- 2026
- Brand names listed
- Alain Mikli, Armani, Arnette, Brooks Brothers, Bulgari, Burberry, Chanel, Chaps and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Air-Conduction Hearing Aid Software | SCR | 2 | Manufacturer | accessdata.fda.gov |
| Frame, Spectacle | HQZ | 1 | Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | 2 | Manufacturer | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Exporter to the US, Foreign private label distributor, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 31, 2025 | K243150 | Nuance Audio Hearing Aid Software | SCR | Substantially Equivalent | Luxottica Group S.P.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of Frame, Spectacle
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
- All makers of Air-Conduction Hearing Aid Software
Updated January 31, 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.