FDA product code LQE: Implant, Corneal, Refractive
LQE is the FDA product code for implant, corneal, refractive. It is a Class III device, reviewed by the Ophthalmic panel. Devices under LQE reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 3 recalls for LQE devices.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Corneal, Refractive |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LQE devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-11-13.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code LQE?
LQE is the FDA product code for implant, corneal, refractive. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is LQE?
Class III. Typical premarket route: PMA.
Have LQE devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2018-11-13.
Next steps
- Run an FDA pathway report with predicate devices for product code LQE
- Run a recall and safety report across every LQE manufacturer
- Watch product code LQE 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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