Marco Ophthalmic, Inc.: FDA clearances and approvals
Marco Ophthalmic, Inc. has 15 FDA 510(k) clearances (first 1992, latest 1994), across 14 product codes in 2 review panels. Median 510(k) review time: 161 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HLM | Instrument, Measuring, Lens, Ac-Powered | 2 | 2 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HJB | Instrument, Measuring, Corneal Radius | 1 | 1 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
| HLF | Device, Measuring, Lens Radius, Ophthalmic | 1 | 1 |
| HME | Chair, Ophthalmic, Ac-Powered | 1 | 1 |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | 1 | 1 |
| HOO | Perimeter, Ac-Powered | 1 | 1 |
| HOS | Projector, Ophthalmic | 1 | 1 |
Plus 4 more product codes.
Review panels
Most recent Marco Ophthalmic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943234 | MS-30 AUTOMATIC PERIMETER | HPT | 1994-07-27 | 21 |
| K930444 | MARCO STANDARD KERATOMETERS | HJB | 1993-08-09 | 195 |
| K930442 | MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS | HKI | 1993-08-09 | 195 |
| K930438 | MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS | HJO | 1993-08-09 | 195 |
| K930437 | MARCO STANDARD RADIUSGAUGES | HLF | 1993-08-09 | 195 |
| K930439 | MARCO SURGISCOPE OPERATION MICROSCOPES | HRM | 1993-07-22 | 177 |
| K930449 | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR | HME | 1993-07-06 | 161 |
| K930447 | MARCO H AND TS-1 INSTRUMENT TABLES | HRJ | 1993-07-06 | 161 |
| K930446 | MARCO TRIAL SETS | HPC | 1993-07-06 | 161 |
| K930443 | MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE | HOS | 1993-07-06 | 161 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Marco Ophthalmic, Inc..
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 Marco Ophthalmic, Inc. have?
Marco Ophthalmic, Inc. has 15 FDA 510(k) clearances (first 1992, latest 1994), across 14 product codes in 2 review panels.
How long does FDA take to clear Marco Ophthalmic, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Marco Ophthalmic, Inc.'s cleared 510(k)s is 161 days.
What devices does Marco Ophthalmic, Inc. make?
Its most frequent FDA product codes are HLM (Instrument, Measuring, Lens, Ac-Powered, 2); GEX (Powered Laser Surgical Instrument, 1); HJB (Instrument, Measuring, Corneal Radius, 1).
Has Marco Ophthalmic, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Marco Ophthalmic, Inc. Related entities may recall under other names.
Next steps
- See all 15 Marco Ophthalmic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HLM, Marco Ophthalmic, Inc.'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.