SOLOS SINGLE USE TITANIUM TIP— 510(k) K874334

Substantially Equivalent

Solos Ophthalmology

FDA 510(k) clearance K874334 for SOLOS SINGLE USE TITANIUM TIP, Substantially Equivalent on 1988-01-11. Applicant: Solos Ophthalmology. Device class: 2.

Clearance details

Applicant
Solos Ophthalmology
Product code
Code HQC
Device class
Class 2
Regulation
21 CFR 886.4670
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Norcross, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HQC

product code HQC
Injury
2,378
Malfunction
8,768
Total
11,146

Source: openFDA MAUDE database, through . 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.