FDA product code MZD: System, In-Office Tinting, Contact Lenses
MZD is the FDA product code for system, in-office tinting, contact lenses. It is a Class II device, regulated under 21 CFR 886.5925 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under MZD. The average 510(k) review took 74 days (median 74).
Classification
| Field | Value |
|---|---|
| Device name | System, In-Office Tinting, Contact Lenses |
| Device class | Class II |
| Regulation | 21 CFR 886.5925 |
| 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 MZD clearance
Top MZD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Softchrome, Inc. | 1 | 1999-08-27 |
Most recent MZD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991995 | Softchrome, Inc. | SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS | 1999-08-27 | 74 |
Recalls for MZD devices
openFDA lists no recalls for product code MZD.
Frequently asked questions
What is FDA product code MZD?
MZD is the FDA product code for system, in-office tinting, contact lenses. It is a Class II device, regulated under 21 CFR 886.5925 and reviewed by the Ophthalmic panel.
What device class is MZD?
Class II, regulation 21 CFR 886.5925. Typical premarket route: 510(k).
How long does a 510(k) take for product code MZD?
Across 1 cleared submissions the average was 74 days from receipt to decision (median 74).
Which companies have the most MZD clearances?
Softchrome, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MZD
- Run a recall and safety report across every MZD manufacturer
- Watch product code MZD 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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