FDA product code QMM: Hydrophilic Re-Coating Solution
QMM is the FDA product code for hydrophilic re-coating solution. It is a Class II device, regulated under 21 CFR 886.5919 and reviewed by the Ophthalmic panel. Devices under QMM reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A hydrophilic re-coating solution is a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components. For prescription use only.
Classification
| Field | Value |
|---|---|
| Device name | Hydrophilic Re-Coating Solution |
| Device class | Class II |
| Regulation | 21 CFR 886.5919 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Recalls for QMM devices
openFDA lists no recalls for product code QMM.
Frequently asked questions
What is FDA product code QMM?
QMM is the FDA product code for hydrophilic re-coating solution. It is a Class II device, regulated under 21 CFR 886.5919 and reviewed by the Ophthalmic panel.
What device class is QMM?
Class II, regulation 21 CFR 886.5919. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QMM
- Run a recall and safety report across every QMM manufacturer
- Watch product code QMM 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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