FDA product code PZK

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

Ophthalmic·Class 3·21 CFR 886.3600·Implantable
US regulatory classifications
US Product Code (FDA)
PZK
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US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR 886.3600
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Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.