FDA Product Code LZU: Plug, Punctum
Leading manufacturers include Visitec Co., Riverpoint Medical and Alphamed, 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
Cleared
Jun 28, 2024
Hello,eyes® BIO Plug
Bio Optics Co., Ltd.
Ophthalmic
57d
Cleared
Dec 23, 2022
Visant Medical Canalicular Plug
Visant Medical, Inc.
Ophthalmic
155d
Cleared
Jun 03, 2022
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
Oasis Medical, Inc.
Ophthalmic
165d
Cleared
Oct 24, 2019
Tear Pool Dissolvable Punctum Plugs
Alphamed, Inc.
Ophthalmic
262d
Cleared
Aug 28, 2015
PDO Absorbable Punctum Plug
Riverpoint Medical
Ophthalmic
204d
Cleared
Oct 12, 1995
VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
Visitec Co.
Ophthalmic
87d
Cleared
Feb 24, 1992
VISITEC CANALICULAR STENT
Visitec Co.
Ophthalmic
62d
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.