DeviceClearance

Product code HQC— Ophthalmic

PHACO TIP

Classification name
Unit, Phacofragmentation
Device class
Class 2
Regulation
21 CFR 886.4670
Advisory panel
Ophthalmic
Total cleared
316
First cleared
Most recent

Market context for product code HQC

FDA has cleared 316 devices under product code HQC between 1977 and 2026, filed by 119 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code HQC

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 →

Recent clearances under product code HQC

1–100 of 316

Data sourced from openFDA. This site is unofficial and independent of the FDA.