Chrysalis Intelligence · Sponsors · Rxsight, Inc.

Rxsight, Inc.

Aliso Viejo, CA, US · 5 510(k) clearances · 39 PMAs

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Total clearances
5
2020-01-17 → 2026-06-10
Last 12 months
1
Product codes
2
Most recent
2026-06-10
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MSS — — — 4 2026-06-10
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic Class II Ophthalmic 1 2020-09-10
Class III

PMA approvals (39)

Total PMA records
39
Originals + supplements
Distinct product codes
1
First decision
2020-05-21
Most recent
2026-06-26
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-06-26 P160055-S054 RxSight Light Adjustable Lens; Light Delivery Device Normal 180 Day Track PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2026-06-08 P160055-S055 RxSight Light Adjustable Lens; Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2025-10-08 P160055-S052 Light Adjustable Lens and Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2025-09-02 P160055-S045 LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) Normal 180 Day Track No User Fee PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2025-07-14 P160055-S051 RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD) 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2025-06-11 P160055-S046 Light Adjustable Lens, Light Delivery System Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2025-05-19 P160055-S044 Light Adjustable Lens and Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2025-05-12 P160055-S048 Light Adjustable Lens and Light Delivery Device 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2025-05-02 P160055-S047 LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2025-04-17 P160055-S043 Light Adjustable Lens, Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2025-02-14 P160055-S042 Light Adjustable Lens and Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2024-12-16 P160055-S041 Light Adjustable Lens, Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2024-12-02 P160055-S037 Light Adjustable Lens and Light Delivery Device 135 Review Track For 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2024-10-31 P160055-S040 Light Adjustable Lens, Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2024-09-03 P160055-S039 Light Adjustable Lens, Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2024-07-29 P160055-S038 Light Adjustable Lens and Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2024-04-08 P160055-S035 Light Adjustable Lens, Light Delivery Device 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2024-03-19 P160055-S034 Light Adjustable Lens, Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2024-02-08 P160055-S033 Light Adjustable Lens and Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2023-10-24 P160055-S032 Light Adjustable Lens, Light Delivery Device 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2023-09-21 P160055-S031 RxSight Light Adjustable Lens and Light Delivery Device 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2023-06-29 P160055-S028 Light Adjustable Lens, Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2023-05-18 P160055-S029 RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD) 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2023-03-31 P160055-S024 Light Adjustable Lens (LAL), Light Delivery Device (LDD) System Normal 180 Day Track PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2023-02-16 P160055-S027 Light Adjustable Lens, Light Delivery Device Normal 180 Day Track No User Fee PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2023-01-31 P160055-S022 Light Adjustable Lens, Light Delivery Device Normal 180 Day Track PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2023-01-12 P160055-S025 Light Adjustable Lens, Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2022-11-30 P160055-S026 Light Adjustable Lens, Light Delivery Device 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2022-07-05 P160055-S023 RxSight Light Adjustable Lens and Light Delivery Device 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2021-10-05 P160055-S021 Light Adjustable Lens, Light Delivery Device Normal 180 Day Track No User Fee PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2021-04-20 P160055-S015 RxSight Light Adjustable Lens and Light Delivery Device Normal 180 Day Track PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2021-04-01 P160055-S019 Light Adjustable Lens (LAL) and Light Delivery Device (LDD) 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2021-03-19 P160055-S018 RxSight Light Adjustable Lens and Light Delivery Device 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2021-03-17 P160055-S014 RxSight Light Adjustable Lens and Light Delivery System 135 Review Track For 30-Day Notice PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2021-03-10 P160055-S017 RxSight Light Adjustable Lens and Light Delivery Device Normal 180 Day Track No User Fee PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2021-02-19 P160055-S016 RxSight Light Adjustable Lens and Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2020-08-07 P160055-S010 RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) Normal 180 Day Track PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2020-05-22 P160055-S009 RxSight Light Adjustable Lens and Light Delivery Device Normal 180 Day Track No User Fee PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
2020-05-21 P160055-S011 RxSight Light Adjustable Lens and Light Delivery Device Real-Time Process PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2026-06-10 K261174 RxSight® Insertion Device MSS — —
2023-08-15 K231838 RxSight® Insertion Device (63002) MSS — —
2023-06-12 K231466 RxSight Insertion Device MSS — —
2020-09-10 K201909 RxSight Contact Lens HJK Class II Ophthalmic
2020-01-17 K192926 RxSight Insertion Device MSS — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence