Data / Medical devices / United States / Raico
Raico: FDA-registered device maker in Westmont, IL, United States, 1 510(k) clearance
Raico is registered with the FDA (registration 3015528097) in Westmont, IL, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 27, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015528097
- Address
- 825 North Cass Avenue 202, Westmont, IL, United States, 60559
- Owner or operator
- RAICO (10060634)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- June 4, 2019
- Registered through
- 2026
- Brand names listed
- HARMONIX Phaco tips, HARMONIX Polymer IA tips, RAICO Trabeculotomy Instruments, iVEnT System ; Tanito GCS ; Espaillat JCS ; Gonio Scrub
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Irrigation, Ocular Surgery | KYG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Specification developer | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Specification developer | accessdata.fda.gov |
| Unit, Phacofragmentation | HQC | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| May 27, 2020 | K192418 | Phacoemulsification Needle (Tip) and Irrigation Sleeve | HQC | Substantially Equivalent | Raico, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Spatula, Ophthalmic
- All makers of Knife, Ophthalmic
- All makers of Device, Irrigation, Ocular Surgery
- All makers of Unit, Phacofragmentation
- All makers of Cannula, Ophthalmic
Updated May 27, 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.