Light Adjustable Lens, Light Delivery

FDA Premarket Approval P160055 S026

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.

Pre-market Approval Supplement Details

• Device: Light Adjustable Lens, Light Delivery
• Generic Name: Light Adjustable Lens (lal) And Light Delivery Device (ldd)
• Applicant: RxSight, Inc.100 Columbiaaliso Viejo, CA 92656 PMA NumberP160055 Supplement NumberS026 Date Received11/09/2022 Decision Date11/30/2022 Product Code PZK Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Date Received: 2022-11-09
• Decision Date: 2022-11-30
• PMA: P160055
• Supplement: S026
• Product Code: PZK
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: RxSight, Inc.; 100 Columbia; aliso Viejo, CA 92656 PMA NumberP160055 Supplement NumberS026 Date Received11/09/2022 Decision Date11/30/2022 Product Code PZK Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement ; the Addition Of An Alternative Foil Pouch Sealer

Supplemental Filings

Supplement Number	Date	Supplement Type
P160055		Original Filing
S026	2022-11-09	30-day Notice
S025
S024
S023	2022-06-09	30-day Notice
S022
S021	2021-09-10	Normal 180 Day Track No User Fee
S020
S019	2021-03-04	30-day Notice
S018	2021-02-25	30-day Notice
S017	2021-02-08	Normal 180 Day Track No User Fee
S016	2020-11-27	Real-time Process
S015
S014
S013
S012
S011	2020-02-27	Real-time Process
S010
S009	2020-01-30	Normal 180 Day Track No User Fee
S008	2019-09-13	Real-time Process
S007	2019-08-19	30-day Notice
S006	2019-05-23	30-day Notice
S005
S004	2019-03-06	30-day Notice
S003	2018-11-07	Normal 180 Day Track No User Fee
S002	2018-09-05	Normal 180 Day Track
S001

NIH GUDID Devices

Device ID	PMA	Supp
00818806020029	P160055	000
00818806021644	P160055	002
00818806020715	P160055	002
00818806020722	P160055	002
00818806020739	P160055	002
00818806020746	P160055	002
00818806020753	P160055	002
00818806020760	P160055	002
00818806020777	P160055	002
00818806020784	P160055	002
00818806020791	P160055	002
00818806020807	P160055	002
00818806020814	P160055	002
00818806020821	P160055	002
00818806020890	P160055	002
00818806020708	P160055	002
00818806020692	P160055	002
00818806020685	P160055	002
00818806020548	P160055	002
00818806020555	P160055	002
00818806020562	P160055	002
00818806020579	P160055	002
00818806020586	P160055	002
00818806020593	P160055	002
00818806020609	P160055	002
00818806020616	P160055	002
00818806020623	P160055	002
00818806020630	P160055	002
00818806020647	P160055	002
00818806020654	P160055	002
00818806020661	P160055	002
00818806020678	P160055	002
00818806020906	P160055	002
00818806020913	P160055	002
00818806020319	P160055	002
00818806020173	P160055	002
00818806020180	P160055	002
00818806020197	P160055	002
00818806020203	P160055	002
00818806020210	P160055	002
00818806020227	P160055	002
00818806020234	P160055	002
00818806020241	P160055	002
00818806020258	P160055	002
00818806020265	P160055	002
00818806020272	P160055	002
00818806020289	P160055	002
00818806020296	P160055	002
00818806020302	P160055	002
00818806020166	P160055	002
00818806020159	P160055	002
00818806020937	P160055	002
00818806020944	P160055	002
00818806020036	P160055	002
00818806020043	P160055	002
00818806020050	P160055	002
00818806020067	P160055	002
00818806020074	P160055	002
00818806020081	P160055	002
00818806020920	P160055	002
00818806020142	P160055	002
00818806020135	P160055	002
00818806020128	P160055	002
00818806020111	P160055	002
00818806020104	P160055	002
00818806020098	P160055	002
00818806021453	P160055	024
00818806021460	P160055	024
00818806021477	P160055	024
00818806021491	P160055	024
00818806021507	P160055	024
00818806021514	P160055	024
00818806021538	P160055	024
00818806021521	P160055	024
00818806021446	P160055	024
00818806021439	P160055	024
00818806021422	P160055	024
00818806021415	P160055	024
00818806021408	P160055	024
00818806021392	P160055	024
00818806021385	P160055	024
00818806021378	P160055	024
00818806021545	P160055	024
00818806021552	P160055	024
00818806021712	P160055	024
00818806021705	P160055	024
00818806021699	P160055	024
00818806021682	P160055	024
00818806021675	P160055	024
00818806021668	P160055	024
00818806021651	P160055	024
00818806021637	P160055	024
00818806021620	P160055	024
00818806021613	P160055	024
00818806021606	P160055	024
00818806021590	P160055	024
00818806021583	P160055	024
00818806021576	P160055	024
00818806021569	P160055	024
00818806021729	P160055	024