Moria SA: FDA clearances and approvals
Moria SA has 5 FDA 510(k) clearances (first 2002, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time: 56 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 29 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Moria SA's cleared 510(k)s took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | 3 | 3 |
| HMY | Keratome, Battery-Powered | 2 | 2 |
Review panels
- Ophthalmic (5)
Most recent Moria SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172994 | EPI K Console | HNO | 2017-10-26 | 29 |
| K043183 | EPI-K | HNO | 2005-03-25 | 128 |
| K032836 | M3 MICROKERATOME | HNO | 2004-06-18 | 281 |
| K040297 | ONEUSE- PLUS MICROKERATOME | HMY | 2004-03-31 | 51 |
| K022560 | M2 SINGLE USE MICROKERTOME | HMY | 2002-09-27 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Moria SA.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Moria SA have?
Moria SA has 5 FDA 510(k) clearances (first 2002, latest 2017), across 2 product codes in 1 review panel.
How long does FDA take to clear Moria SA's 510(k)s?
The median time from FDA receipt to decision across Moria SA's cleared 510(k)s is 56 days.
What devices does Moria SA make?
Its most frequent FDA product codes are HNO (Keratome, Ac-Powered, 3); HMY (Keratome, Battery-Powered, 2).
Has Moria SA had device recalls?
openFDA lists no recalls under a recalling firm name matching Moria SA. Related entities may recall under other names.
Next steps
- See all 5 Moria SA clearances with predicates and recalls
- Run predicate analysis for product code HNO, Moria SA's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.