FDA product code MYC: Ophthalmoscope, Laser, Scanning
MYC is the FDA product code for ophthalmoscope, laser, scanning. It is a Class II device, regulated under 21 CFR 886.1570 and reviewed by the Ophthalmic panel. FDA has cleared 23 510(k) submissions under MYC, 3 in the last five years, from 9 different applicants. The average 510(k) review took 147 days (median 116); 179 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Ophthalmoscope, Laser, Scanning |
| Device class | Class II |
| Regulation | 21 CFR 886.1570 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MYC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 128 |
| 2019 | 1 | 102 |
| 2021 | 2 | 68 |
| 2025 | 2 | 210 |
| 2026 | 1 | 148 |
Compare with all 510(k) review times · Search every MYC clearance
Top MYC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Centervue S.P.A. | 9 | 2025-03-17 |
| Optos Plc. | 6 | 2015-01-16 |
| Carl Zeiss Meditec, Inc. | 2 | 2009-11-25 |
| Kowa Company, Ltd. Chofu Factory | 1 | 2026-09-11 |
| Ocusciences, Inc. | 1 | 2025-04-22 |
4 more applicants have MYC clearances. See the full list in Caduvo.
Most recent MYC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261255 | Kowa Company, Ltd. Chofu Factory | KOWA FM-600 | 2026-09-11 | 148 |
| K241931 | Ocusciences, Inc. | OcuMet Beacon (OCUB100) | 2025-04-22 | 295 |
| K243504 | Centervue S.P.A. | MAIA (AHMACME001) | 2025-03-17 | 125 |
| K213705 | Centervue S.P.A. | DRSplus | 2021-12-21 | 27 |
| K211328 | Centervue S.P.A. | EIDON FA, EIDON, EIDON AF, EIDON UWFL | 2021-08-19 | 108 |
Recalls for MYC devices
openFDA lists no recalls for product code MYC.
Frequently asked questions
What is FDA product code MYC?
MYC is the FDA product code for ophthalmoscope, laser, scanning. It is a Class II device, regulated under 21 CFR 886.1570 and reviewed by the Ophthalmic panel.
What device class is MYC?
Class II, regulation 21 CFR 886.1570. Typical premarket route: 510(k).
How long does a 510(k) take for product code MYC?
Across 23 cleared submissions the average was 147 days from receipt to decision (median 116).
Which companies have the most MYC clearances?
Centervue S.P.A. (9); Optos Plc. (6); Carl Zeiss Meditec, Inc. (2); Kowa Company, Ltd. Chofu Factory (1); Ocusciences, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MYC
- Run a recall and safety report across every MYC manufacturer
- Watch product code MYC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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