PZK — Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Class III
FDA product code PZK covers "Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)", a Class III medical device regulated under 21 CFR 886.3600. Submissions are reviewed by the Ophthalmic panel. Devices under this code are implants.
Classification Details
- Product Code
- PZK
- Device Class
- Class III
- Regulation Number
- 886.3600
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- Yes
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.