SOFT LENS FOLDER— 510(k) K861990

Name: FDA 510(k) clearance K861990
Creator: U.S. Food and Drug Administration
Published: 1986-06-17

Substantially Equivalent

Staar Surgical Co.

FDA 510(k) clearance K861990 for SOFT LENS FOLDER, Substantially Equivalent on 1986-06-17. Applicant: Staar Surgical Co.. Device class: 1.

Clearance details

Applicant: Staar Surgical Co.
Product code: Code KYB
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 1986-05-23
Decision date: 1986-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

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K090161 — EPIPHANY INJECTION SYSTEM2009-06-09
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K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S2004-06-10
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Adverse events under product code KYB

product code KYB

Injury: 218
Malfunction: 1,989
Other: 1
Total: 2,208

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.