BAILEY LENS SHOOTER— 510(k) K841730

Substantially Equivalent

Intermedics Intraocular, Inc.

FDA 510(k) clearance K841730 for BAILEY LENS SHOOTER, Substantially Equivalent on 1984-11-19. Applicant: Intermedics Intraocular, Inc..

Clearance details

Applicant: Intermedics Intraocular, Inc.
Product code: Code KYB
Advisory panel: Ophthalmic
Date received: 1984-04-25
Decision date: 1984-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freeport, TX, US

Download summary PDF View on FDA.gov ↗

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.