FDA applicant

Rxsight, Inc.

Aliso Viejo, CA7 decisions2017–20260 recalls

FDA records 7 decisions for Rxsight, Inc. (Aliso Viejo, CA) from 2017 to 2026: 6 510(k) clearances and 1 original PMA approval. Most are in product codes MSS (Folders And Injectors, Intraocular Lens (Iol)) and HJK (Lens, Contact, Polymethylmethacrylate…). Its devices cite 9 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Rxsight, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2017high 2 (2020) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Rxsight, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Rxsight, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?