Data / Medical devices / Chile / Industria Optica Rodenstock Chile S. A
Industria Optica Rodenstock Chile S. A: FDA-registered device maker in Santiago , Region Metropolitana, Chile, 2 510(k) clearances
Industria Optica Rodenstock Chile S. A is registered with the FDA (registration 3004848970) in Santiago , Region Metropolitana, Chile. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 29, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004848970
- Address
- Avenida Beaucheff N 1581 Santiago, Santiago , Region Metropolitana, Chile, 8370719
- Owner or operator
- Rodenstock GmbHElsenheimer (10061326)
- Roles
- Exporter to the US
- First device listed
- October 8, 2019
- Registered through
- 2026
- Brand names listed
- DNEye Scanner 2, DNEye Scanner 2+, DNEye Scanner 3 (HKI), Porche Design Sunglasses, Porsche Design Sunglasses, Rodenstock Sunglasses, VX118, VX120
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Exporter to the US | accessdata.fda.gov |
| Frame, Spectacle | HQZ | 1 | Exporter to the US | accessdata.fda.gov |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | 1 | Exporter to the US | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Exporter to the US | accessdata.fda.gov |
| Tonometer, Ac-Powered | HKX | 2 | Exporter to the US | 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 29, 2021 | K202221 | VX650 | HKI | Substantially Equivalent | Luneau Technology Operations | accessdata.fda.gov |
| June 1, 2015 | K143086 | VX120 Ophthalmic Diagnostic Device | HKX | Substantially Equivalent | Luneau Sas | accessdata.fda.gov |
Compare with other makers
- All makers of Tonometer, Ac-Powered
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of Frame, Spectacle
- All makers of Camera, Ophthalmic, Ac-Powered
- All makers of Lens, Spectacle, Non-Custom (Prescription)
Updated January 29, 2021. 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.