Data / Medical devices / United States / Oculus Surgical Inc
Oculus Surgical Inc: FDA-registered device maker in Port St Lucie, FL, United States, 1 510(k) clearance
Oculus Surgical Inc is registered with the FDA (registration 3009773841) in Port St Lucie, FL, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 29, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009773841
- Address
- 9850 SW Discovery Way, Port St Lucie, FL, United States, 34987
- Owner or operator
- Oculus Surgical Inc (10042000)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 20, 2018
- Registered through
- 2026
- Brand names listed
- BIOM 6 HD Optic Set, Contact Lens, HD Professional, Cohen-Benner Contact "CBC", GONIO ready® CL, General surgery tray, SUPER VIEW® Lens Set, Disposable, SUPER VIEW® Lens Set, Disposable HD Plus, for RESIGHT, SUPER VIEW® Lens Set, Disposable HD, for RESIGHT, SUPER VIEW® Lens Set, Disposable, Essential and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| General Surgery Tray | LRO | 2 | Manufacturer | accessdata.fda.gov |
| Lens, Condensing, Diagnostic | HJL | 1 | Manufacturer | accessdata.fda.gov |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | 2 | Manufacturer | accessdata.fda.gov |
| Prism, Gonioscopic | HKS | 1 | Manufacturer | accessdata.fda.gov |
| Retractor, Ophthalmic | HNI | 1 | Contract manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 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 29, 2005 | K051630 | SUPER VIEW DISPOSABLE BIOM LENS SET | HJK | Substantially Equivalent | Insight Instruments, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact, Polymethylmethacrylate, Diagnostic
- All makers of Prism, Gonioscopic
- All makers of Tray, Surgical, Instrument
- All makers of Lens, Condensing, Diagnostic
- All makers of General Surgery Tray
- All makers of Retractor, Ophthalmic
Updated June 29, 2005. 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.