PZK
- Product code
- PZK
- Device name
- Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
- Device class
- Class 3
- 21 CFR
- 21 CFR 886.3600
- Medical specialty
- Ophthalmic
- Marketing pathway
- PMA
- Flag
- Implant
FDA classification 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.
Official FDA classification page: PZK
Classification and pathway per current FDA publications. Data from openFDA (CC0).