DeviceClearance

Product code HQF— Ophthalmic

Iridex 810 Laser

Classification name
Laser, Ophthalmic
Device class
Class 2
Regulation
21 CFR 886.4390
Advisory panel
Ophthalmic
Total cleared
180
First cleared
Most recent

Market context for product code HQF

FDA has cleared 180 devices under product code HQF between 1978 and 2026, filed by 84 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 HQF

Adverse events under product code HQF

product code HQF
Injury
166
Other
1
Total
167

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 HQF

1–100 of 180

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