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 Quantel Medical, Lightmed Corp. and Nidek, Inc..

180
Total
180
Cleared
125d
Avg days
1978
Since
180 devices
49–72 of 180
Cleared May 15, 2013
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
K123542
Topcon Medical Laser Systems, Inc.
Ophthalmic · 177d
Cleared Nov 13, 2012
PASCAL LASER INDIRECT OPHTHALMOSCOPE
K123056
Topcon Medical Laser Systems, Inc. (Tmls)
Ophthalmic · 43d
Cleared Sep 17, 2012
KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES
K121187
Katalyst Surgical, LLC
Ophthalmic · 151d
Cleared Sep 14, 2012
SUPRA SCAN DELIVERY SYSTEM
K120825
Quantel Medical
Ophthalmic · 179d
Cleared Aug 20, 2012
OPTO HYALUS GREEN LASER
K111460
Opto Eletronica S/A
Ophthalmic · 452d
Cleared Mar 16, 2012
FEMTO LDV
K112154
Sie Ag,Surgical Instument Engineering
Ophthalmic · 233d
Cleared Nov 03, 2011
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
K103547
Lightmed Corp.
Ophthalmic · 336d
Cleared Nov 03, 2011
OPTO MITRA YELLOW LASER
K111643
Opto Electronica SA
Ophthalmic · 143d
Cleared Aug 11, 2011
PASCAL STREAMLINE 577 (WITH ACCESSORIES)
K111108
Topcon Medical Laser Systems, Inc.
Ophthalmic · 113d
Cleared Feb 01, 2011
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
K103056
Carl Zeiss Meditec, AG
Ophthalmic · 109d
Cleared Jul 08, 2010
VISUMAX LASER KERATOME
K100253
Carl Zeiss Meditec, AG
Ophthalmic · 161d
Cleared May 04, 2010
PASCAL STREAMLINE PHOTOCOAGULATOR
K100019
Optimedica Corporation
Ophthalmic · 119d
Cleared Oct 27, 2009
NAVILAS LASER SYSTEM
K091064
Od-Os GmbH
Ophthalmic · 196d
Cleared Sep 28, 2009
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
K091981
Lightmed Corp.
Ophthalmic · 89d
Cleared Sep 25, 2009
PASCAL STREAMLINE PHOTOCOAGULATOR
K092621
Topcon Medical Laser Systems, Inc.
Ophthalmic · 30d
Cleared Sep 18, 2009
LIGHTLAS MODEL 532
K091534
Lightmed Corp.
Ophthalmic · 115d
Cleared Aug 13, 2009
LIGHTLAS SELECTOR
K090774
Lightmed Corp.
Ophthalmic · 143d
Cleared Jun 16, 2009
SUPRA 577.Y LASER
K091581
Quantel Medical
Ophthalmic · 14d
Cleared Mar 25, 2009
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
K081946
Quantel Medical
Ophthalmic · 260d
Cleared Sep 12, 2008
SOLX 790 TITANIUM SAPPHIRE LASER
K081774
Solx, Inc.
Ophthalmic · 81d
Cleared Jul 02, 2008
INTEGRE PRO, MODEL L2RY
K081565
Ellex Medical Pty, Ltd.
Ophthalmic · 28d
Cleared Mar 11, 2008
INTEGRE, MODEL LP581
K080423
Ellex Medical Pty, Ltd.
Ophthalmic · 25d
Cleared Dec 14, 2007
MERILAS 532A
K072823
Meridian AG
Ophthalmic · 73d
Cleared Nov 05, 2007
NEXT GENERATION LASER
K062624
Alcon Laboratories
Ophthalmic · 426d