RxSight Light Adjustable Lens (LAL) and Light Delivery Device
FDA premarket approval P160055/S002 · decided 2019-03-04
Approval details
- PMA number
- P160055
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RxSight Light Adjustable Lens (LAL) and Light Delivery Device
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Applicant
- Rxsight, Inc.
- Date received
- 2018-09-05
- Decision date
- 2019-03-04
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- PZK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval for the post-approval study protocol, RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study, and modifications to the LAL posterior layer, the LAL haptic attachment manufacturing process, and the LDD light source, table configuration, infrared anterior segment illumination, and contact lens.
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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 |