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 Carl Zeiss Meditec, AG.
List of Laser, Ophthalmic devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Laser, Ophthalmic devices (product code HQF). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Ophthalmic FDA review panel. Browse all Ophthalmic devices →