HQB · Class II · 21 CFR 886.4690

FDA Product Code HQB: Photocoagulator And Accessories

Leading manufacturers include Peregrine Surgical , Ltd., Nidek, Inc. and Surgical Laser Technologies, Inc..

30
Total
30
Cleared
120d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Photocoagulator And Accessories Devices (Product Code HQB)

30 devices
1–24 of 30
Cleared Nov 03, 2022
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
K220263
Vortex Surgical, Inc.
Ophthalmic · 276d
Cleared Dec 23, 2019
MAXReach Laser Probe
K191846
Vortex Surgical, Inc.
Ophthalmic · 166d
Cleared May 01, 2019
Vitreq disposable laser probes, light fibers and Chandelier
K182646
Vitreq BV
Ophthalmic · 219d
Cleared Nov 14, 2013
PEREGRINE CURVED ILLUMINATING LASER PROBE
K132614
Peregrine Surgical , Ltd.
Ophthalmic · 85d
Cleared Jun 26, 2013
23GA CURVED ILLUMINATING LASER PROBE
K122997
Peregrine Surgical , Ltd.
Ophthalmic · 272d
Cleared Apr 30, 2013
PEREGRINE 23GA CURVED LASER PROBE
K122905
Peregrine Surgical , Ltd.
Ophthalmic · 221d
Cleared Apr 23, 2012
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
K113857
Synergetics, Inc.
Ophthalmic · 115d
Cleared Oct 17, 2011
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
K110951
Alcon Research, Ltd.
Ophthalmic · 196d
Cleared Jul 27, 2011
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
K111493
Nidek Co., Ltd.
Ophthalmic · 57d
Cleared Feb 23, 2011
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
K110228
Nidek Incorporated
Ophthalmic · 28d
Cleared Jan 22, 1997
LC-250 INFRARED LIGHT COAGULATOR
K964380
Nk-Optik America
Ophthalmic · 79d
Cleared Jul 09, 1992
ZIESS ENDOPROBE
K922735
Carl Zeiss, Inc.
Ophthalmic · 31d
Cleared Dec 14, 1988
SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION
K882679
Surgical Laser Technologies, Inc.
Ophthalmic · 169d
Cleared Sep 26, 1988
SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION
K882441
Surgical Laser Technologies, Inc.
Ophthalmic · 104d
Cleared Jun 06, 1988
REUSABLE FIBEROPTIC LIGHTPIPE
K881926
Advanced Surgical Products, Inc.
Ophthalmic · 28d
Cleared Feb 07, 1986
NIDEK AC-2000 LASER SYSTEM
K860011
Nidek, Inc.
Ophthalmic · 35d
Cleared May 16, 1985
SYSTEM 930 ARGON PHOTOCOAGULATOR
K844356
Coherent Medical Group
Ophthalmic · 188d
Cleared Feb 06, 1985
ARGON/KRYPTON LASER SYSTEM 8500
K844209
Cooper Lasersonics, Inc.
Ophthalmic · 98d
Cleared Dec 24, 1984
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
K844197
Nidek, Inc.
Ophthalmic · 55d
Cleared Dec 24, 1984
ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE
K844198
Nidek, Inc.
Ophthalmic · 55d
Cleared Nov 08, 1984
ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS
K843966
American Medical Optics
Ophthalmic · 28d
Cleared Sep 16, 1980
SLIT LAMP ATTACHMENT
K801877
Cavitron Corp.
Ophthalmic · 41d
Cleared May 09, 1978
PHOTOCOAGULATOR LASER
K780345
Cavitron Corp.
Ophthalmic · 69d
Cleared Dec 13, 1977
LAMP DELIVERY SYS.-PHOTOCOAGULATION
K772213
Varian Assoc., Inc.
Ophthalmic · 11d

About Product Code HQB - Regulatory Context

510(k) Submission Activity

30 total 510(k) submissions under product code HQB since 1976, with 30 receiving FDA clearance (average review time: 120 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.