Light Adjustable Lens, Light Delivery Device
FDA premarket approval P160055/S032 · decided 2023-10-24
Approval details
- PMA number
- P160055
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Light Adjustable Lens, Light Delivery Device
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Applicant
- Rxsight, Inc.
- Date received
- 2023-09-29
- Decision date
- 2023-10-24
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- PZK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- the addition of an alternate anterior layer silicone material mixing method used during manufacturing of the RxSight Intraocular Lenses (IOL)(parent LAL model 60005 and the LAL+ model 60007)
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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 |