Light Adjustable Lens and Light Delivery Device
FDA premarket approval P160055/S052 · decided 2025-10-08
Approval details
- PMA number
- P160055
- Supplement
- S052
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Light Adjustable Lens and Light Delivery Device
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Applicant
- Rxsight, Inc.
- Date received
- 2025-07-11
- Decision date
- 2025-10-08
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- PZK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval for updates to the Light Delivery Device (LDD) Model 61002-006 software and Model 61002-007 software that include minor enhancements to the graphical user interface (GUI), improvements to internal manufacturing and service tools, software processing optimizations, and resolution of identified bugs
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RxSight® Insertion Device (K261174) | Rxsight, Inc. | 2026-06-10 |
| RxSight® Insertion Device (63002) (K231838) | Rxsight, Inc. | 2023-08-15 |
| RxSight Insertion Device (K231466) | Rxsight, Inc. | 2023-06-12 |
| RxSight Contact Lens (K201909) | Rxsight, Inc. | 2020-09-10 |
| RxSight Insertion Device (K192926) | Rxsight, Inc. | 2020-01-17 |
| RxSight Insertion Device (K181401) | Rxsight, Inc. | 2018-07-26 |