Data / Medical devices / United States / ICU Eyecare Solutions Inc.
ICU Eyecare Solutions Inc.: FDA-registered device maker in Hollister, CA, United States, 1 510(k) clearance
ICU Eyecare Solutions Inc. is registered with the FDA (registration 2936829) in Hollister, CA, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2936829
- Address
- 1900 Shelton Dr, Hollister, CA, United States, 95023
- Owner or operator
- ICU Eyecare Solutions Inc. (10091386)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 13, 2024
- Registered through
- 2026
- Brand names listed
- Eyecare, Magnifying, Mask, Reading, Sunglasses
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Case, Contact Lens | LRX | 2 | Specification developer | accessdata.fda.gov |
| Magnifier, Hand-Held, Low-Vision | HJF | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Manufacturer | accessdata.fda.gov |
| Spectacle, Magnifying | HOI | 1 | Manufacturer | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Manufacturer | accessdata.fda.gov |
| System, Reading, Television, Closed-Circuit | HJG | 1 | 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 |
|---|---|---|---|---|---|---|
| June 6, 2000 | K991206 | BONASSE CONTACT LENS CASE | LRX | Substantially Equivalent | Bonasse Ent. Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Magnifier, Hand-Held, Low-Vision
- All makers of Case, Contact Lens
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of System, Reading, Television, Closed-Circuit
- All makers of Mask, Scavenging
- All makers of Spectacle, Magnifying
Updated June 6, 2000. 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.