FDA Product Code HQF: Laser, Ophthalmic
Under FDA product code HQF, ophthalmic lasers are cleared for a broad range of therapeutic applications in eye diseases.
These lasers use different wavelengths and pulse modes to photocoagulate retinal lesions, cut posterior capsule opacification, open angle structures in glaucoma, and reshape the cornea for refractive correction. Common types include argon, Nd:YAG, diode, and excimer lasers.
HQF devices are Class II medical devices, regulated under 21 CFR 886.4390 and reviewed by the FDA Ophthalmic panel.
Leading manufacturers include Quantel Medical, Carl Zeiss Meditec, Inc. and Meridian AG.
FDA 510(k) Cleared Laser, Ophthalmic Devices (Product Code HQF)
About Product Code HQF - Regulatory Context
510(k) Submission Activity
180 total 510(k) submissions under product code HQF since 1978, with 180 receiving FDA clearance (average review time: 125 days).
Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 11 in the prior period.
FDA Review Time
Recent submissions under HQF have taken an average of 230 days to reach a decision - up from 121 days historically. Manufacturers should account for longer review timelines in current project planning.
HQF devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →