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 Nidek, Inc., Carl Zeiss Meditec, AG and Iridex Corporation.