FDA Product Code HQB: Photocoagulator And Accessories
Leading manufacturers include Vortex Surgical, Inc. and Vitreq BV.
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
Cleared
Nov 03, 2022
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
Vortex Surgical, Inc.
Ophthalmic
276d
Cleared
Dec 23, 2019
MAXReach Laser Probe
Vortex Surgical, Inc.
Ophthalmic
166d
Cleared
May 01, 2019
Vitreq disposable laser probes, light fibers and Chandelier
Vitreq BV
Ophthalmic
219d
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.