Ophtec BV: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Ophtec BV”, plus 2 PMA decisions, across 2 product codes in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MRJ | Ring, Endocapsular | 1 | 0 |
| MTA | Lens, Intraocular, Phakic | 1 | 0 |
Review panels
- Ophthalmic (2)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P030028 | PMA | ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL) | 2004-09-10 |
| P030023 | PMA | OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US | 2004-04-27 |
Recalls
openFDA lists no recalls under a recalling firm named Ophtec BV.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Ophtec BV is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04632784: Clinical Trial With Artiflex Presbyopic (Artiplus) (Active not recruiting, started 2021-11-12)
- NCT02409771: Clinical Trial With PRECIZON Presbyopic (Completed, started 2015-06)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ophtec, USA (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ophtec BV?
FDA lists 0 510(k) clearances under the applicant name “Ophtec BV”, plus 2 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Ophtec BV?
The most frequent FDA product codes under this applicant name are MRJ (Ring, Endocapsular, 1); MTA (Lens, Intraocular, Phakic, 1).
Next steps
- See all 0 Ophtec BV clearances with predicates and recalls
- Run predicate analysis for product code MRJ, Ophtec BV's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.