PMA approvals

RxSight Light Adjustable Lens and Light Delivery Device

Rxsight, Inc. · Light adjustable lens (LAL) and light delivery device (LDD) · Ophthalmic

P160055 S058SupplementOK30
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PMA number
P160055
Supplement number
S058
Applicant
Rxsight, Inc.
Street 1
100 Columbia
City
Aliso Viejo
State
CA
Zip
92656
Generic name
Light adjustable lens (LAL) and light delivery device (LDD)
Trade name
RxSight Light Adjustable Lens and Light Delivery Device
Product code
PZK
Advisory committee
OP
Advisory committee description
Ophthalmic
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited review flag
N
Date received
2026-09-22
Decision date
2026-10-22
Decision code
OK30
Ao statement
changing the location of supplier manufacturing site for a critical raw precursor material to LAL/LAL+ devices
Harmonized identifiers (openFDA)
Device name
Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
Medical specialty description
Ophthalmic
Regulation number
886.3600
Device class
3
Registration number
3012712027, 2030624
FEI number
3012712027, 3000206435
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.