Light Adjustable Lens, Light Delivery Device
FDA premarket approval P160055/S035 · decided 2024-04-08
Approval details
- PMA number
- P160055
- Supplement
- S035
- 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
- 2024-03-12
- Decision date
- 2024-04-08
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- PZK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- changes to the overall size of the outer shelf-unit box and secondary shipping (foil) pouch for the RxSight LAL/LAL+ (models 60005 and 60007), and modifications to the artwork design on the shelf-unit box to reflect updated company branding and recent trademark registrations
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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 |