SOLOS EYESITE CAP SLEEVE— 510(k) K872611

Substantially Equivalent

Solos Ophthalmology

FDA 510(k) clearance K872611 for SOLOS EYESITE CAP SLEEVE, Substantially Equivalent on 1987-08-10. Applicant: Solos Ophthalmology.

Clearance details

Applicant: Solos Ophthalmology
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1987-07-06
Decision date: 1987-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, 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.