FDA product code LPM: Lenses, Soft Contact, Extended Wear
LPM is the FDA product code for lenses, soft contact, extended wear. It is a Class III device, regulated under 21 CFR 886.5925 and reviewed by the Ophthalmic panel. Devices under LPM reach the market by PMA; FDA lists no cleared 510(k)s for it. 45 PMA applications cite this product code. FDA has posted 26 recalls for LPM devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lenses, Soft Contact, Extended Wear |
| Device class | Class III |
| Regulation | 21 CFR 886.5925 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
Recalls for LPM devices
26 product recalls in 18 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2025-06-16.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 2 |
| 2020 | 2 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code LPM?
LPM is the FDA product code for lenses, soft contact, extended wear. It is a Class III device, regulated under 21 CFR 886.5925 and reviewed by the Ophthalmic panel.
What device class is LPM?
Class III, regulation 21 CFR 886.5925. Typical premarket route: PMA.
Have LPM devices been recalled?
Yes: 26 product recalls across 18 recall events; the most recent began 2025-06-16.
Next steps
- Run an FDA pathway report with predicate devices for product code LPM
- Run a recall and safety report across every LPM manufacturer
- Watch product code LPM 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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