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
73–96 of 180
Cleared Sep 20, 2007
LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
K063297
Lightmed Corp.
Ophthalmic · 323d
Cleared Apr 24, 2007
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR
K070776
Quantel Medical
Ophthalmic · 34d
Cleared Nov 14, 2006
IRIDEX WIRELESS FOOTSWITCH
K062074
Iridex Corp
Ophthalmic · 116d
Cleared Jun 21, 2006
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
K061024
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
K051944
Lumenis, Inc.
Ophthalmic · 74d
Cleared Sep 21, 2005
20G SMA LASER FIBER, MODEL LF100
K050807
Ophthalmed, LLC
Ophthalmic · 175d
Cleared May 09, 2005
OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY
K050541
Omniguide Communications, Inc.
Ophthalmic · 68d
Cleared Mar 24, 2005
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II
K043613
Quantel Medical
Ophthalmic · 84d
Cleared Feb 07, 2005
FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA
K043236
Quantel Medical
Ophthalmic · 77d
Cleared Oct 06, 2004
LASEREX, MODEL LP4532
K041598
Ellex Medical Pty, Ltd.
Ophthalmic · 114d
Cleared Sep 20, 2004
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
K040209
Iridex Corp
Ophthalmic · 234d
Cleared Feb 10, 2004
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
K033941
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Aug 27, 2003
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
K031665
Iridex Corp
Ophthalmic · 90d
Cleared Jun 27, 2003
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
K031023
Peregrine Surgical , Ltd.
Ophthalmic · 88d
Cleared Dec 17, 2002
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
K023094
Quantel Medical
Ophthalmic · 90d
Cleared Aug 08, 2002
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
K021538
Lightmed Corp.
Ophthalmic · 90d
Cleared May 03, 2002
OCULIGHT SL/SLX
K020374
Iridex Corp
Ophthalmic · 88d
Cleared Feb 11, 2002
DC-3300 LASER DIODE PHOTOCOAGULATOR
K013760
Nidek, Inc.
Ophthalmic · 90d
Cleared Aug 22, 2001
LIGHTLAS 532 PHOTOCOAGULATOR
K010372
Lightmed Corp.
Ophthalmic · 196d
Cleared Jul 06, 2000
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
K001772
Taracan Pty. , Ltd.
Ophthalmic · 24d
Cleared May 17, 1999
BQ/BM INTEGRATED LASER DELIVERY SYSTEM
K990665
American Laser Corp.
Ophthalmic · 76d
Cleared Mar 30, 1999
LPULSA SYL-9000 OPHTHALMIC YAG LASER
K990075
Light-Med(Usa), Inc.
Ophthalmic · 78d
Cleared Jun 17, 1998
MEDITEC LINK
K981196
Aesculap-Meditec North America
Ophthalmic · 90d
Cleared Nov 21, 1997
LUXSCOPE
K973193
Luxtec Corp.
Ophthalmic · 88d