Data / Medical devices / United States / OptiMedica Corp.
OptiMedica Corp.: FDA-registered device maker in Milpitas, CA, United States, 4 510(k) clearances
OptiMedica Corp. is registered with the FDA (registration 3005675890) in Milpitas, CA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated September 20, 2016. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005675890
- Address
- 510 Cottonwood Dr, Milpitas, CA, United States, 95035
- Owner or operator
- Johnson & Johnson Surgical Vision, Inc. (10053607)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 22, 2016
- Registered through
- 2026
- Brand names listed
- Ophthalmic Femtosecond Laser, Ophthalmic femtosecond laser
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ophthalmic Femtosecond Laser | OOE | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 20, 2016 | K161455 | Catalys Precision Laser System | OOE | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| September 11, 2014 | K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | OOE | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| August 28, 2012 | K121091 | CATALYS PRECISION LASER SYSTEM | OOE | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| December 21, 2011 | K113479 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | OOE | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 20, 2015 | 70672 | Class II | Terminated | Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surg | Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters. | accessdata.fda.gov |
| December 20, 2013 | 67150 | Class II | Terminated | Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiM | Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke. | accessdata.fda.gov |
Compare with other makers
Updated September 20, 2016. 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.