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
Sep 20, 2007
LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
Lightmed Corp.
Ophthalmic
323d
Cleared
Apr 24, 2007
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR
Quantel Medical
Ophthalmic
34d
Cleared
Nov 14, 2006
IRIDEX WIRELESS FOOTSWITCH
Iridex Corp
Ophthalmic
116d
Cleared
Jun 21, 2006
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
Peregrine Surgical , Ltd.
Ophthalmic
69d
Cleared
Sep 30, 2005
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
Lumenis, Inc.
Ophthalmic
74d
Cleared
Sep 21, 2005
20G SMA LASER FIBER, MODEL LF100
Ophthalmed, LLC
Ophthalmic
175d
Cleared
May 09, 2005
OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY
Omniguide Communications, Inc.
Ophthalmic
68d
Cleared
Mar 24, 2005
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II
Quantel Medical
Ophthalmic
84d
Cleared
Feb 07, 2005
FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA
Quantel Medical
Ophthalmic
77d
Cleared
Oct 06, 2004
LASEREX, MODEL LP4532
Ellex Medical Pty, Ltd.
Ophthalmic
114d
Cleared
Sep 20, 2004
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
Iridex Corp
Ophthalmic
234d
Cleared
Feb 10, 2004
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
Bausch & Lomb, Inc.
Ophthalmic
53d
Cleared
Aug 27, 2003
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
Iridex Corp
Ophthalmic
90d
Cleared
Jun 27, 2003
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
Peregrine Surgical , Ltd.
Ophthalmic
88d
Cleared
Dec 17, 2002
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
Quantel Medical
Ophthalmic
90d
Cleared
Aug 08, 2002
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
Lightmed Corp.
Ophthalmic
90d
Cleared
May 03, 2002
OCULIGHT SL/SLX
Iridex Corp
Ophthalmic
88d
Cleared
Feb 11, 2002
DC-3300 LASER DIODE PHOTOCOAGULATOR
Nidek, Inc.
Ophthalmic
90d
Cleared
Aug 22, 2001
LIGHTLAS 532 PHOTOCOAGULATOR
Lightmed Corp.
Ophthalmic
196d
Cleared
Jul 06, 2000
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
Taracan Pty. , Ltd.
Ophthalmic
24d
Cleared
May 17, 1999
BQ/BM INTEGRATED LASER DELIVERY SYSTEM
American Laser Corp.
Ophthalmic
76d
Cleared
Mar 30, 1999
LPULSA SYL-9000 OPHTHALMIC YAG LASER
Light-Med(Usa), Inc.
Ophthalmic
78d
Cleared
Jun 17, 1998
MEDITEC LINK
Aesculap-Meditec North America
Ophthalmic
90d
Cleared
Nov 21, 1997
LUXSCOPE
Luxtec Corp.
Ophthalmic
88d