Data / Medical devices / Japan / Hoya Surgical Research Center
Hoya Surgical Research Center: FDA-registered device maker in Tokyo, Japan, 1 510(k) clearance and 1 PMA approval
Hoya Surgical Research Center is registered with the FDA (registration 3008344633) in Tokyo, Japan. 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. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008344633
- Address
- Helios II Bldg,3F 1-12-11, Funado, Itabashi-ku, Tokyo, Japan, 174-0041
- Owner or operator
- Hoya Surgical Research Center (10032157)
- Roles
- Specification developer
- First device listed
- April 14, 2010
- Registered through
- 2026
- Brand names listed
- Hoya-IS Injector System, IPure B1PC, IPure B1PY, IPure B3PC, IPure B3PY, iSert preloaded IOL System (Model No. 230), iSert preloaded IOL System (Model No. 231), iSert preloaded IOL System (Model No. 250) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Specification developer | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | 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 |
|---|---|---|---|---|---|---|
| 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 |
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.