Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
PZK · Class III — High Risk (PMA approval required, life-sustaining) · Ophthalmic · 21 CFR 886.3600
Classification
FDA Product Code
PZK
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 886.3600
Review panel
OP
Medical specialty
Ophthalmic
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.