OptiMedica Corp.
Milpitas, CA, US
OptiMedica Corp. appears in FDA device records in Milpitas, CA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for OptiMedica Corp. between 2006 and 2016. The busiest year on record is 2006, with 1. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161455 | Catalys Precision Laser System | OOE | Substantially Equivalent | |
| K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | OOE | Substantially Equivalent | |
| K121091 | CATALYS PRECISION LASER SYSTEM | OOE | Substantially Equivalent | |
| K113479 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | OOE | Substantially Equivalent | |
| K100019 | PASCAL STREAMLINE PHOTOCOAGULATOR | HQF | Substantially Equivalent | |
| K091666 | PASCAL PHOTOCOAGULATOR, PASCAL-US | GEX | Substantially Equivalent | |
| K081744 | PASCAL SYNTHESIS DELIVERY SYSTEM | GEX | Substantially Equivalent | |
| K062336 | OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005675890 | 3005675890 | OptiMedica Corp. | 510 Cottonwood Dr, Milpitas, CA 95035 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1683-2015 | 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 surgery for removal of the crystalline lens. | 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. | Class II | Terminated | |
| Z-0649-2014 | 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. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain