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 TypeOptical
Radition SafetyProduct
Annual ReportsNo

Products Classified as PZK

4415Light Adjustable Lens (lal) And Light Delivery Device (ldd)Intraocular Lens.

Total Product Life Cycle (TPLC) Devices

4415Light Adjustable Lens (lal) And Light Delivery Device (ldd)Intraocular Lens.

Pre-market Approvals for PZK

P160055Light Adjustable Lens (LAL) and Light Delivery (LDD)RxSight, Inc.

Global Unique Device Identification Database

00818806020319Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020302Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020296Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020289Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020272Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020265Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020258Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020241Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020234Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020227Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020210Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020203Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020197Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020180Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
00818806020173Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

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