Optimedica Corporation
Optimedica Corporation holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2016, with 2 FDA device recalls on record.
Top product codes for Optimedica Corporation
FDA recalls by Optimedica Corporation
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Optimedica Corporation
- K161455 — Catalys Precision Laser System
- K141079 — OPTIMEDICA CATALYS PRECISION LASER SYSTEM
- K121091 — CATALYS PRECISION LASER SYSTEM
- K113479 — OPTIMEDICA CATALYS PRECISION LASER SYSTEM
- K100019 — PASCAL STREAMLINE PHOTOCOAGULATOR
- K091666 — PASCAL PHOTOCOAGULATOR, PASCAL-US
- K081744 — PASCAL SYNTHESIS DELIVERY SYSTEM
- K062336 — OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.