PZKClass III

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

21 CFR 886.3600 / Ophthalmic

PZK is the FDA product code for Light Adjustable Lens (Lal) And Light Delivery Device (Ldd), a class III device type, regulated under 21 CFR 886.3600. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PZK
Device name: Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
FDA 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.
Regulation: 21 CFR 886.3600
Device class: Class III
Review panel: Ophthalmic
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PZK

FDA records hold no clearances under product code PZK.

Recent recalls

Product code PZK

FDA records show no recalls under product code PZK.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)