| 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 Code | PZK |
|---|
| Premarket Review |
Ophthalmic Devices
(DHT1A)
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 |
