Data / Medical devices / Finland / Optomed
Optomed: FDA-registered device maker in Oulu Pohjois-Pohjanmaa, Finland, 5 510(k) clearances
Optomed is registered with the FDA (registration 3007710608) in Oulu Pohjois-Pohjanmaa, Finland. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 20, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007710608
- Address
- Yrttipellontie 1, Oulu Pohjois-Pohjanmaa, Finland, 90230
- Owner or operator
- Optomed Oyj (10029840)
- Roles
- Exporter to the US, Specification developer
- First device listed
- August 2, 2011
- Registered through
- 2027
- Brand names listed
- Bosch Eye Camera, Bosch Eye Camera SWAN, Bosch Eye cam anterior module, Bosch Eye cam posterior module, HAAG-STREIT FUNDUS MODULE 300, Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module, Optomed Lumo Camera, Pictor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Camera, Ophthalmic, General-Use | PJZ | 2 | 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 |
|---|---|---|---|---|---|---|
| November 20, 2020 | K201325 | Optomed Smartscope M5 with Optomed Smartscope FA | HKI | Substantially Equivalent | Optomed Oyj | accessdata.fda.gov |
| April 5, 2018 | K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | HKI | Substantially Equivalent | Optomed OY | accessdata.fda.gov |
| April 11, 2017 | K163021 | HAAG-STREIT FUNDUS MODULE 300 | HKI | Substantially Equivalent | Optomed OY | accessdata.fda.gov |
| December 18, 2013 | K132186 | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 | HKI | Substantially Equivalent | Optomed OY | accessdata.fda.gov |
| May 16, 2011 | K110986 | OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 | HKI | Substantially Equivalent | Optomed OY | accessdata.fda.gov |
Compare with other makers
Updated November 20, 2020. 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.