Stellaris Elite vision enhancement system— 510(k) K170052

Substantially Equivalent

Bausch+Lomb

FDA 510(k) clearance K170052 for Stellaris Elite vision enhancement system, Substantially Equivalent on 2017-04-19. Applicant: Bausch+Lomb.

Clearance details

Applicant: Bausch+Lomb
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2017-01-05
Decision date: 2017-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
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.