FDA product code MWL: Lens, Contact (Rigid Gas Permeable), Extended Wear
MWL is the FDA product code for lens, contact (rigid gas permeable), extended wear. It is a Class III device, regulated under 21 CFR 886.5916 and reviewed by the Ophthalmic panel. Devices under MWL reach the market by PMA; FDA lists no cleared 510(k)s for it. 8 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Contact (Rigid Gas Permeable), Extended Wear |
| Device class | Class III |
| Regulation | 21 CFR 886.5916 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
Recalls for MWL devices
openFDA lists no recalls for product code MWL.
Frequently asked questions
What is FDA product code MWL?
MWL is the FDA product code for lens, contact (rigid gas permeable), extended wear. It is a Class III device, regulated under 21 CFR 886.5916 and reviewed by the Ophthalmic panel.
What device class is MWL?
Class III, regulation 21 CFR 886.5916. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MWL
- Run a recall and safety report across every MWL manufacturer
- Watch product code MWL 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.