RxSight® Insertion Device— 510(k) K261174

Name: FDA 510(k) clearance K261174
Creator: U.S. Food and Drug Administration
Published: 2026-06-10

Substantially Equivalent

Rxsight, Inc.

FDA 510(k) clearance K261174 for RxSight® Insertion Device, Substantially Equivalent on 2026-06-10. Applicant: Rxsight, Inc.. Device class: 1.

Summary

RxSight's RxSight Insertion Device is filed under MSS, intraocular lens (IOL) folders and injectors. The record gives no model numbers or description beyond the name.

Class I, 21 CFR 886.4300. Ophthalmic is both the classification panel and the review panel, and the submission was a Special 510(k).

RxSight filed from Aliso Viejo, California. Review took 62 calendar days (April 9 to June 10, 2026).

Clearance details

Applicant: Rxsight, Inc.
Product code: Product code MSS
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 2026-04-09
Decision date: 2026-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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K231106 — Accuject Refra Injector AR29002023-09-19
K231838 — RxSight® Insertion Device (63002)2023-08-15
K231466 — RxSight Insertion Device2023-06-12

More clearances from Rxsight, Inc.

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K201909 — RxSight Contact Lens2020-09-10
K192926 — RxSight Insertion Device2020-01-17
K181401 — RxSight Insertion Device2018-07-26

Adverse events under product code MSS

product code MSS

Injury: 385
Malfunction: 2,033
Total: 2,418

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.