LZU

FDA Product Code LZU: Plug, Punctum

Leading manufacturers include Oasis Medical, Inc., Lacrimedics, Inc. and Fci Ophthalmics, Inc..

49
Total
49
Cleared
111d
Avg days
1989
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Plug, Punctum Devices (Product Code LZU)

49 devices
1–24 of 49
Cleared Jun 28, 2024
Hello,eyes® BIO Plug
K241229
Bio Optics Co., Ltd.
Ophthalmic · 57d
Cleared Dec 23, 2022
Visant Medical Canalicular Plug
K222164
Visant Medical, Inc.
Ophthalmic · 155d
Cleared Jun 03, 2022
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
K213988
Oasis Medical, Inc.
Ophthalmic · 165d
Cleared Oct 24, 2019
Tear Pool Dissolvable Punctum Plugs
K190210
Alphamed, Inc.
Ophthalmic · 262d
Cleared Apr 17, 2017
Soft Plug Extended Duration 180 Canalicular Plug
K162361
Oasis Medical, Inc.
Ophthalmic · 237d
Cleared Nov 18, 2016
LacriPro Punctum Plug
K161673
Lacrimedics, Inc.
Ophthalmic · 155d
Cleared Aug 28, 2015
PDO Absorbable Punctum Plug
K150288
Riverpoint Medical
Ophthalmic · 204d
Cleared Nov 13, 2014
VERAPLUG
K140352
Krishna Imports Inc Dba Stephens Instruments
Ophthalmic · 274d
Cleared Jun 20, 2014
COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
K140711
Paragon Bioteck, Inc.
Ophthalmic · 91d
Cleared Jun 03, 2014
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
K140026
Lacrimedics, Inc.
Ophthalmic · 148d
Cleared Jun 04, 2009
FLOW CONTROLLER
K090938
Odyssey Medical, Inc.
Ophthalmic · 62d
Cleared Jul 11, 2006
SNUG PLUG PUNCTUM PLUG
K061398
Fci Ophthalmics, Inc.
Ophthalmic · 53d
Cleared May 02, 2006
EAGLEVISION GELLANSERTS, MODEL REF 0040
K053333
Eagle Vision, Inc.
Ophthalmic · 152d
Cleared Aug 19, 2005
DELTA PUNCTUM PLUG
K050851
Delta Life Science, Inc.
Ophthalmic · 137d
Cleared Jul 26, 2002
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
K020882
Surgical Specialties Corp
Ophthalmic · 130d
Cleared Jun 27, 2002
SOFT PLUG ABSORBABLE PLUG-SA
K013613
Oasis Medical, Inc.
Ophthalmic · 234d
Cleared Apr 20, 1999
FLEXPLUG
K991130
Eagle Vision, Inc.
Ophthalmic · 18d
Cleared May 11, 1998
SURGIDEV SILICONE PUNCTUM PLUG
K980844
Advanced Vision Science
Ophthalmic · 68d
Cleared Apr 30, 1998
SILICONE PUNCTAL PLUG
K980437
Oasis Medical, Inc.
Ophthalmic · 85d
Cleared Sep 09, 1997
PUNCTUAL OCCLUDER
K972523
Odyssey Medical, Inc.
Ophthalmic · 64d
Cleared Apr 23, 1997
PUNCTUAL OCCLUDER
K970631
Odyssey Medical, Inc.
Ophthalmic · 63d
Cleared Apr 14, 1997
HERRICK ULTIMATE PUNCTUM PLUG
K963501
Lacrimedics, Inc.
Ophthalmic · 223d
Cleared Apr 14, 1997
HERRICK ULTIMATE PUNCTUM PLUG
K963708
Lacrimedics, Inc.
Ophthalmic · 210d
Cleared Dec 20, 1996
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
K964774
Fci Ophthalmics, Inc.
Ophthalmic · 59d

About Product Code LZU - Regulatory Context

510(k) Submission Activity

49 total 510(k) submissions under product code LZU since 1989, with 49 receiving FDA clearance (average review time: 111 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.