FDA product code MYD: Keratome, Water Jet
MYD is the FDA product code for keratome, water jet. It is a Class I device, regulated under 21 CFR 886.4370 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under MYD. The average 510(k) review took 567 days (median 567).
Classification
| Field | Value |
|---|---|
| Device name | Keratome, Water Jet |
| Device class | Class I |
| Regulation | 21 CFR 886.4370 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MYD clearance
Top MYD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Visijet, Inc. | 1 | 2000-10-20 |
Most recent MYD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991124 | Visijet, Inc. | VISIJET HYDROKERATOME, MODEL 50 | 2000-10-20 | 567 |
Recalls for MYD devices
openFDA lists no recalls for product code MYD.
Frequently asked questions
What is FDA product code MYD?
MYD is the FDA product code for keratome, water jet. It is a Class I device, regulated under 21 CFR 886.4370 and reviewed by the Ophthalmic panel.
What device class is MYD?
Class I, regulation 21 CFR 886.4370. Typical premarket route: 510(k).
How long does a 510(k) take for product code MYD?
Across 1 cleared submissions the average was 567 days from receipt to decision (median 567).
Which companies have the most MYD clearances?
Visijet, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MYD
- Run a recall and safety report across every MYD manufacturer
- Watch product code MYD 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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