HQE · Class II · 21 CFR 886.4150

FDA Product Code HQE: Instrument, Vitreous Aspiration And Cutting, Ac-powered

Leading manufacturers include Storz Instrument Co., Medical Instrument Development Laboratories, Inc. and CooperVision, Inc..

149
Total
149
Cleared
114d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Instrument, Vitreous Aspiration And Cutting, Ac-powered Devices (Product Code HQE)

149 devices
1–24 of 149
Cleared Aug 10, 2022
UniVit HE, UniVit UHS
K212763
Visioncare Devices, LLC
Ophthalmic · 344d
Cleared Sep 27, 2017
Cetus system, Cetus probe
K170183
A.R.C Laser GmbH
Ophthalmic · 247d
Cleared Apr 29, 2016
Bi-Blade Vitrectomy Cutter
K153168
Medical Instrument Development Laboratories
Ophthalmic · 179d
Cleared Aug 22, 2014
CONSTELLATION VISION SYSTEM
K141065
Alcon Research, Ltd.
Ophthalmic · 120d
Cleared Jun 21, 2012
VERSAVIT
K121675
Synergetics, Inc.
Ophthalmic · 15d
Cleared May 30, 2012
PROCARE PLUS VITRECTOMY SYSTEM
K120170
Visioncare Devices, Inc.
Ophthalmic · 132d
Cleared Apr 08, 2011
ULTIMATE VIT ENHAMCER (UVE)
K102222
Medical Instrument Development Laboratories, Inc.
Ophthalmic · 245d
Cleared Apr 29, 2002
MID LABS AUTONOMOUS VIT ENHANCER (AVE)
K020911
Medical Instrument Development Laboratories, Inc.
Ophthalmic · 40d
Cleared Dec 10, 1999
VIT ENHANCER
K992943
Medical Instrument Development Laboratories, Inc.
Ophthalmic · 101d
Cleared Nov 19, 1999
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
K990292
Ophthalmic Consultants, Inc.
Ophthalmic · 294d
Cleared Mar 03, 1999
D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
K983797
Dutch Ophthalmic USA, Inc.
Ophthalmic · 126d
Cleared Apr 30, 1998
PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20
K980399
Peregrine Surgical , Ltd.
Ophthalmic · 87d
Cleared Apr 30, 1998
PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
K980400
Peregrine Surgical , Ltd.
Ophthalmic · 87d
Cleared Mar 23, 1998
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
K980488
Storz Instrument Co.
Ophthalmic · 42d
Cleared May 06, 1997
REUSABLE VITRECTOMY PROBE
K970670
Altex Vision
Ophthalmic · 71d
Cleared May 05, 1997
DISPOSABLE VITRECTOMY PROBE
K970673
Altex Vision
Ophthalmic · 70d
Cleared Feb 03, 1997
STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
K964743
Storz Instrument Co.
Ophthalmic · 69d
Cleared Nov 25, 1996
VIT COMMANDER SYSTEM
K961738
Scieran Technologies, Inc.
Ophthalmic · 206d
Cleared Sep 18, 1996
STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
K960061
Storz Instrument Co.
Ophthalmic · 258d
Cleared Jun 14, 1996
AUTOMATED VITRECTOMY DEVICE
K961078
Promex, Inc.
Ophthalmic · 88d
Cleared Mar 04, 1996
STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX
K954816
Storz Instrument Co.
Ophthalmic · 136d
Cleared Sep 14, 1995
STORZ MVS-3201 VITRECTOMY PROBE PACK
K953575
Storz Instrument Co.
Ophthalmic · 45d
Cleared Sep 14, 1995
STORZ DP4505 VITREOUS MEMBRANE DISSECTOR
K953576
Storz Instrument Co.
Ophthalmic · 45d
Cleared Apr 18, 1995
INFINITECH ASPIRATING LASER PROBE
K946135
Surgical Technologies, Inc.
Ophthalmic · 123d

About Product Code HQE - Regulatory Context

510(k) Submission Activity

149 total 510(k) submissions under product code HQE since 1977, with 149 receiving FDA clearance (average review time: 114 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.