HQB · Class II · 21 CFR 886.4690

FDA Product Code HQB: Photocoagulator And Accessories

Leading manufacturers include Nidek, Inc., Vortex Surgical, Inc. and Varian Assoc., 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 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 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 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
Cleared Aug 26, 1976
PHOTOCOAGULATOR, LOG 3 PORTABLE XENON
K760444
Varian Assoc., Inc.
Ophthalmic · 10d

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.