Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | RxSight Light Adjustable Lens and Light Delivery Device |
Generic Name | Light adjustable lens (LAL) and light delivery device (LDD) |
Regulation Number | 886.3600 |
Applicant | RxSight, Inc. 100 Columbia Aliso Viejo, CA 92656 |
PMA Number | P160055 |
Supplement Number | S015 |
Date Received | 10/22/2020 |
Decision Date | 04/20/2021 |
Product Code |
PZK |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for (1) a simplified fixed output beam aperture in place of the current motorized aperture, (2) update to LDD lock-in treatment profile to reduce ocular exposure, (3) update to the Windows 10 operating system, (4) extension of dioptric power range to include +4.0 to +9.0 diopters, (5) introduce an additional UV-A absorber to the anterior portion of the LAL, and (6) updates to manufacturing work instructions, LDD Graphical User Interface (GUI), and user labeling to reflect all modifications. |
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