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U.S. Department of Health and Human Services

Product Classification

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Device light adjustable lens (lal) and light delivery device (ldd)
Regulation Description Intraocular lens.
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.
Physical State An intraocular lens made of a polymeric material with an appropriate shape to be implanted to replace the natural lens of an eye after cataract surgery. The energy source is a device that produces an appropriate external energy source to alter the shape or optical properties of the lens.
Technical Method The intraocular lens is implanted within the eye and the external energy source is used to alter the material property within the lens to compensate for postoperative refractive error.
Target Area Eye
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodePZK
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type PMA
Regulation Number 886.3600
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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