# Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PZK)
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