CATALYS PRECISION LASER SYSTEM— 510(k) K121091
Substantially EquivalentOptimedica Corporation
FDA 510(k) clearance K121091 for CATALYS PRECISION LASER SYSTEM, Substantially Equivalent on 2012-08-28. Applicant: Optimedica Corporation. Device class: 2.
Clearance details
- Applicant
- Optimedica Corporation
- Product code
- Code OOE
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code OOE
view allMore clearances from Optimedica Corporation
view allAdverse events under product code OOE
product code OOE- Injury
- 1,104
- Malfunction
- 864
- Total
- 1,968
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K121091
K-number listed on FDA's recall record- Z-0066-2019 — OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
- 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121091.
Data sourced from openFDA. This site is unofficial and independent of the FDA.