MicroSTAAR Injector System Cartridges— 510(k) K172375

Name: FDA 510(k) clearance K172375
Creator: U.S. Food and Drug Administration
Published: 2017-09-06

Substantially Equivalent

STAAR Surgical Company

FDA 510(k) clearance K172375 for MicroSTAAR Injector System Cartridges, Substantially Equivalent on 2017-09-06. Applicant: STAAR Surgical Company. Device class: 1.

Clearance details

Applicant: STAAR Surgical Company
Product code: Code MSS
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 2017-08-07
Decision date: 2017-09-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

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K152357 — MicroSTAAR Injector System Cartridges2015-10-30

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.