HOYA IS INJECTOR SYSTEM— 510(k) K081346

Substantially Equivalent

Hoya Surgical Optics, Inc.

FDA 510(k) clearance K081346 for HOYA IS INJECTOR SYSTEM, Substantially Equivalent on 2009-03-23. Applicant: Hoya Surgical Optics, Inc..

Clearance details

Applicant: Hoya Surgical Optics, Inc.
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2008-05-14
Decision date: 2009-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chino Hills, CA, US

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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.