Data / Medical devices / United States / Hoya Surgical Optics, Inc.
Hoya Surgical Optics, Inc.: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance and 1 PMA approval
Hoya Surgical Optics, Inc. is registered with the FDA (registration 3006723646) in Irvine, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated March 23, 2009. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006723646
- Address
- 110 Progress Ave., Suite 175, Irvine, CA, United States, 92618
- Owner or operator
- Hoya Surgical Optics, Inc. (10026397)
- Roles
- Complaint file establishment
- First device listed
- January 21, 2009
- Registered through
- 2026
- Brand names listed
- Hoya-IS Injector and Cardtridges (Model No. ISH001, ISH003), Hoya-IS Injectors and Cartridges (Cartridge Model No. E1), IPure B1PC, IPure B1PY, IPure B3PC, IPure B3PY, PreVue C, PreVue Y and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Complaint file establishment | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| March 23, 2009 | K081346 | HOYA IS INJECTOR SYSTEM | MSS | Substantially Equivalent | Hoya Surgical Optics, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 26, 2008 | P080004 | HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS | HQL | 45 | October 25, 2023 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 17, 2011 | 59207 | Not yet classified | Terminated | iSymm Intraocular Lens (Model FC-60AD) The Hoya iSymm Model FC-60AD Intraocular Lens (IOL) is an ultraviolet-light absorbing posterior chamber intraocular lens designed to be implanted posterior to the iris where the len | The recall was initiated because Hoya Surgical Optics has confirmed that the iSymm Intraocular Lens (Model FC-60AD) and iSert Intraocular Lens (Model PC-60AD) have been sold and marketed with out an FDA approval. | accessdata.fda.gov |
Compare with other makers
Updated October 25, 2023. 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.