Data / Medical devices / United States / Fci Ophthalmics, Inc.
Fci Ophthalmics, Inc.: FDA-registered device maker in Pembroke, MA, United States, 2 510(k) clearances and 1 PMA approval
Fci Ophthalmics, Inc. is registered with the FDA (registration 1225124) in Pembroke, MA, United States. It lists 3 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated June 24, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1225124
- FEI number
- 3000210020
- Address
- 30 Corporate Park Drive Suite #310/320, Pembroke, MA, United States, 02359
- Owner or operator
- Carl Zeiss Meditec AG (Jena) (9053564)
- Roles
- Complaint file establishment
- First device listed
- July 17, 2019
- Registered through
- 2026
- Brand names listed
- EZYPOR, FCI Prolong Plug, Morcher CTR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implant, Eye Sphere | HPZ | 2 | Complaint file establishment | accessdata.fda.gov |
| Plug, Punctum | LZU | U | Complaint file establishment | accessdata.fda.gov |
| Ring, Endocapsular | MRJ | 3 | Complaint file establishment | 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 24, 2022 | K212741 | EZYPOR | HPZ | Substantially Equivalent | Fci (France Chirurgie Instrumentation) Sas | accessdata.fda.gov |
| April 17, 2017 | K162361 | Soft Plug Extended Duration 180 Canalicular Plug | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 23, 2003 | P010059 | MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C | MRJ | 10 | November 4, 2024 | accessdata.fda.gov |
Compare with other makers
Updated November 4, 2024. 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.