HQF · Class II · 21 CFR 886.4390

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 Iridex Corporation, Norlase Aps and Quantel Medical.

180

Total

180

Cleared

125d

Avg days

1978

Since

Declining activity - 7 submissions in the last 2 years vs 11 in the prior period

Review times increasing: avg 230d recently vs 121d historically

FDA 510(k) Cleared Laser, Ophthalmic Devices (Product Code HQF)

180 devices

1–24 of 180

Cleared Apr 07, 2026

Voyager DSLT (430840610)

Navilas Laser System 577sl (156691)

Leos Laser and Endoscopy System

K240615

Beaver-Visitec International, Inc.

Carl Zeiss Meditec, AG

Carl Zeiss Meditec, Inc.

Ophthalmic · 225d

Cleared Sep 12, 2023

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse

Lutronic Vision, Inc.

Ophthalmic · 267d

Cleared Nov 09, 2022

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

K222395

Ellex Medical Pty, Ltd.

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

K212630

Ellex Medical Pty, Ltd.

Ophthalmic · 119d

Cleared Dec 07, 2020

Ophthalmic Yag Laser System YC-200

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 510(k) Review Time - HQF Product Code

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 →

FDA Product Code HQF: Laser, Ophthalmic

FDA 510(k) Cleared Laser, Ophthalmic Devices (Product Code HQF)

About Product Code HQF - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - HQF Product Code

Related FDA 510(k) Regulatory Insights