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