Data / Medical devices / Netherlands / Ophtec BV
Ophtec BV: FDA-registered device maker in Groningen, Netherlands, 1 510(k) clearance and 2 PMA approvals
Ophtec BV is registered with the FDA (registration 8040449) in Groningen, Netherlands. It lists 4 device types. The FDA files 1 510(k) clearance and 2 PMA approvals under its listings, the newest dated September 10, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8040449
- FEI number
- 3002501070
- Address
- Schweitzerlaan 15, Groningen, Netherlands, 9728 NR
- Owner or operator
- OPHTEC USA (8040449)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- June 30, 1997
- Registered through
- 2026
- Brand names listed
- ARTISAN Enclavation Forceps, ARTISAN Implantation Forceps, ARTISAN Lens Manipulator, Artifix Holding Forceps, Artiflex Myopia Phakic Lens, Artisan - Artiflex Enclavation Needle, Artisan Myopia Phakic Lens, Ophtec Capsular Tension Ring and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Forceps, Ophthalmic | HNR | 1 | Exporter to the US | accessdata.fda.gov |
| Hook, Ophthalmic | HNQ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lens, Intraocular, Phakic | MTA | 3 | Manufacturer | accessdata.fda.gov |
| Ring, Endocapsular | MRJ | 3 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 17, 2003 | K030471 | OPHTEC ENCLAVATION NEEDLE | HNQ | Substantially Equivalent | Ophtec, USA | 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 |
|---|---|---|---|---|---|---|
| September 10, 2004 | P030028 | ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL) | MTA | 11 | April 24, 2026 | accessdata.fda.gov |
| April 27, 2004 | P030023 | OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US | MRJ | 10 | October 6, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Forceps, Ophthalmic
- All makers of Hook, Ophthalmic
- All makers of Lens, Intraocular, Phakic
- All makers of Ring, Endocapsular
Updated April 24, 2026. 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.