| 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 |
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| Generic Name | Light adjustable lens (LAL) and light delivery device (LDD) |
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| Regulation Number | 886.3600 |
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| Applicant | Rxsight, Inc.
100 Columbia
Aliso Viejo, CA 92656 |
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| PMA Number | P160055 |
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| Supplement Number | S015 |
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| Date Received | 10/22/2020 |
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| Decision Date | 04/20/2021 |
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| Product Code |
PZK |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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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