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 R
| Device Type ID | 4415 |
| Device Name | Light Adjustable Lens (lal) And Light Delivery Device (ldd) |
| 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 Sh |
| 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 Description | Intraocular Lens. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Intraocular And Corneal Implants Devices Branch (ICIB) |
| Submission Type | PMA |
| CFR Regulation Number | 886.3600 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PZK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4415 |
| Device | Light Adjustable Lens (lal) And Light Delivery Device (ldd) |
| Product Code | PZK |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Intraocular Lens. |
| CFR Regulation Number | 886.3600 [🔎] |