RxSight® Insertion Device (63002)— 510(k) K231838

Substantially Equivalent

Rxsight, Inc.

FDA 510(k) clearance K231838 for RxSight® Insertion Device (63002), Substantially Equivalent on 2023-08-15. Applicant: Rxsight, Inc..

Clearance details

Applicant: Rxsight, Inc.
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2023-06-22
Decision date: 2023-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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.