STELLARIS VISION ENHANCEMENT SYSTEM— 510(k) K133242

Substantially Equivalent

Bausch & Lomb

FDA 510(k) clearance K133242 for STELLARIS VISION ENHANCEMENT SYSTEM, Substantially Equivalent on 2014-02-14. Applicant: Bausch & Lomb.

Clearance details

Applicant: Bausch & Lomb
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2013-10-21
Decision date: 2014-02-14
Decision: Substantially Equivalent
Clearance type: Special
Location: St Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.