Light Adjustable Lens (lal) And Light Delivery Device (ldd)
Product Code: PZK
Ophthalmic Ultraviolet Medical Products
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.
Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]
Code of Federal Regulations: 886.3600
Radiation Type | Optical |
Radition Safety | Product |
Annual Reports | No |
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