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LZU — Plug, Punctum Class U

FDA Device Classification

FDA product code LZU covers "Plug, Punctum", a Class U medical device. Submissions are reviewed by the Unknown panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LZU
Device Class
Class U
Regulation Number
Submission Type
Review Panel
OP
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241229Bio Optics CoHello,eyes® BIO PlugJun 28, 2024
K222164Visant MedicalVisant Medical Canalicular PlugDec 23, 2022
K213988Oasis MedicalSOFT PLUG Extended Duration 180 Tapered Canalicular PlugJun 3, 2022
K190210AlphamedTear Pool Dissolvable Punctum PlugsOct 24, 2019
K162361Oasis MedicalSoft Plug Extended Duration 180 Canalicular PlugApr 17, 2017
K161673LacrimedicsLacriPro Punctum PlugNov 18, 2016
K150288Riverpoint MedicalPDO Absorbable Punctum PlugAug 28, 2015
K140352Krishna Imports Inc Dba Stephens InstrumentsVERAPLUGNov 13, 2014
K140711Paragon BioteckCOMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUJun 20, 2014
K140026LacrimedicsCOLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TESTJun 3, 2014
K090938Odyssey MedicalFLOW CONTROLLERJun 4, 2009
K061398Fci OphthalmicsSNUG PLUG PUNCTUM PLUGJul 11, 2006
K053333Eagle VisionEAGLEVISION GELLANSERTS, MODEL REF 0040May 2, 2006
K050851Delta Life ScienceDELTA PUNCTUM PLUGAug 19, 2005
K040912Partners In BiomaterialsHYDROGEL CANALICULAR PLUGNov 16, 2004
K040231AlconINTELIPORT OCCLUDING DEVICEJul 13, 2004
K030300LacrimedicsOPAQUE HERRICK LACRIMAL PLUGMay 9, 2003
K022043MedenniumSMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503Oct 18, 2002
K021936Moist MedicalMOIST PUNCTAL PLUG SYSTEMOct 16, 2002
K020882Surgical SpecialtiesSHARPOINT ULTRAPLUG EXTENDED WEAR PLUGJul 26, 2002

FDA data resources