Product code PZK
- Device name
- Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
- Medical specialty
- Ophthalmic
- Device class
- 3
- Regulation number
- 886.3600
- Review panel
- OP
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P160055S052 | Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | 2025-10-08 |
| P160055S045 | LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) | Rxsight, Inc. | 2025-09-02 |
| P160055S051 | RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD) | Rxsight, Inc. | 2025-07-14 |
| P160055S046 | Light Adjustable Lens, Light Delivery System | Rxsight, Inc. | 2025-06-11 |
| P160055S044 | Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | 2025-05-19 |
| P160055S048 | Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | 2025-05-12 |
| P160055S047 | LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) | Rxsight, Inc. | 2025-05-02 |
| P160055S043 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2025-04-17 |
| P160055S042 | Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | 2025-02-14 |
| P160055S041 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2024-12-16 |
| P160055S037 | Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | 2024-12-02 |
| P160055S040 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2024-10-31 |
| P160055S039 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2024-09-03 |
| P160055S038 | Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | 2024-07-29 |
| P160055S035 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2024-04-08 |
| P160055S034 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2024-03-19 |
| P160055S033 | Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | 2024-02-08 |
| P160055S032 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2023-10-24 |
| P160055S031 | RxSight Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | 2023-09-21 |
| P160055S028 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2023-06-29 |
| P160055S029 | RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD) | Rxsight, Inc. | 2023-05-18 |
| P160055S024 | Light Adjustable Lens (LAL), Light Delivery Device (LDD) System | Rxsight, Inc. | 2023-03-31 |
| P160055S027 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2023-02-16 |
| P160055S022 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2023-01-31 |
| P160055S025 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2023-01-12 |
| P160055S026 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2022-11-30 |
| P160055S023 | RxSight Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | 2022-07-05 |
| P160055S021 | Light Adjustable Lens, Light Delivery Device | Rxsight, Inc. | 2021-10-05 |
| P160055S015 | RxSight Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | 2021-04-20 |
| P160055S019 | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Rxsight, Inc. | 2021-04-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00818806022498 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2025-10-17 |
| 00818806022504 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2025-10-17 |
| 00818806022511 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2025-10-17 |
| 00818806022528 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2025-10-17 |
| 00818806022535 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2025-10-17 |
| 00818806022481 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2025-10-17 |
| 00818806021736 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2024-12-04 |
| 00818806021743 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2024-12-04 |
| 00818806021484 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2024-12-04 |
| 00818806020951 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2024-12-04 |
| 00818806020869 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2024-12-04 |
| 00818806020852 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2024-12-04 |
| 00818806021552 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021545 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021538 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021521 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021514 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021507 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021491 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021477 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021460 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021453 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021446 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021439 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021422 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021415 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021408 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021392 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021385 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |
| 00818806021378 | Light Adjustable Lens (LAL) | RXSIGHT, INC. | 2023-05-01 |