FDA product code PZK: Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
PZK is the FDA product code for light adjustable lens (lal) and light delivery device (ldd). It is a Class III device, regulated under 21 CFR 886.3600 and reviewed by the Ophthalmic panel. Devices under PZK reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The system consists of an intraocular lens and an external energy source. The lens is intended to be implanted to replace the natural lens of an eye. The external energy source is used to postoperatively alter the properties of the lens material to reduce the likelihood of clinically significant postoperative refractive error.
Classification
| Field | Value |
|---|---|
| Device name | Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) |
| Device class | Class III |
| Regulation | 21 CFR 886.3600 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PZK devices
openFDA lists no recalls for product code PZK.
Frequently asked questions
What is FDA product code PZK?
PZK is the FDA product code for light adjustable lens (lal) and light delivery device (ldd). It is a Class III device, regulated under 21 CFR 886.3600 and reviewed by the Ophthalmic panel.
What device class is PZK?
Class III, regulation 21 CFR 886.3600. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PZK
- Run a recall and safety report across every PZK manufacturer
- Watch product code PZK 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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