Product Code: LZU FDA unclassified

Plug, Punctum

Unknown

The Punctum Plug (product code LZU) is a small device inserted into the lacrimal punctum (the small opening in the corner of the eyelid) to block drainage of tears, used in the treatment of dry eye syndrome by increasing tear film retention on the ocular surface. It is currently unclassified (Class U) with no assigned regulation number or formal medical specialty, and is reviewed under the Ophthalmic (OP) panel. As an unclassified device, its regulatory pathway has not been fully determined. It is not flagged as an implant or life-sustaining device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LZU
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 49 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241229	Hello,eyes® BIO Plug	Jun 28, 2024	Substantially Equivalent	Bio Optics Co., Ltd.
K222164	Visant Medical Canalicular Plug	Dec 23, 2022	Substantially Equivalent	Visant Medical, Inc.
K213988	SOFT PLUG Extended Duration 180 Tapered Canalicular Plug	Jun 03, 2022	Substantially Equivalent	Oasis Medical, Inc.
K190210	Tear Pool Dissolvable Punctum Plugs	Oct 24, 2019	Substantially Equivalent	Alphamed, Inc.
K162361	Soft Plug Extended Duration 180 Canalicular Plug	Apr 17, 2017	Substantially Equivalent	Oasis Medical, Inc.
K161673	LacriPro Punctum Plug	Nov 18, 2016	Substantially Equivalent	Lacrimedics, Inc.
K150288	PDO Absorbable Punctum Plug	Aug 28, 2015	Substantially Equivalent	Riverpoint Medical
K140352	VERAPLUG	Nov 13, 2014	Substantially Equivalent	Krishna Imports Inc Dba Stephens Instruments
K140711	COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,	Jun 20, 2014	Substantially Equivalent	Paragon Bioteck, Inc.
K140026	COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST	Jun 03, 2014	Substantially Equivalent	Lacrimedics, Inc.
K090938	FLOW CONTROLLER	Jun 04, 2009	Substantially Equivalent	Odyssey Medical, Inc.
K061398	SNUG PLUG PUNCTUM PLUG	Jul 11, 2006	Substantially Equivalent	Fci Ophthalmics, Inc.
K053333	EAGLEVISION GELLANSERTS, MODEL REF 0040	May 02, 2006	Substantially Equivalent	Eagle Vision, Inc.
K050851	DELTA PUNCTUM PLUG	Aug 19, 2005	Substantially Equivalent	Delta Life Science, Inc.
K040912	HYDROGEL CANALICULAR PLUG	Nov 16, 2004	Substantially Equivalent	Partners IN Biomaterials, Inc.
K040231	INTELIPORT OCCLUDING DEVICE	Jul 13, 2004	Substantially Equivalent	Alcon, Inc.
K030300	OPAQUE HERRICK LACRIMAL PLUG	May 09, 2003	Substantially Equivalent	Lacrimedics, Inc.
K022043	SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503	Oct 18, 2002	Substantially Equivalent	Medennium, Inc.
K021936	MOIST PUNCTAL PLUG SYSTEM	Oct 16, 2002	Substantially Equivalent	Moist Medical, Inc.
K020882	SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG	Jul 26, 2002	Substantially Equivalent	Surgical Specialties Corp
K021831	OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB	Jul 01, 2002	Substantially Equivalent	Lacrimedics, Inc.
K013613	SOFT PLUG ABSORBABLE PLUG-SA	Jun 27, 2002	Substantially Equivalent	Oasis Medical, Inc.
K001768	OCCU-FLO PUNCTUM PLUGS	Sep 19, 2000	Substantially Equivalent	U.S. Iol, Inc.
K001234	BIOINSULATED SILICONE PUNCTUM PLUG	Jul 11, 2000	Substantially Equivalent	Advanced Vision Science
K001737	OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM	Jun 19, 2000	Substantially Equivalent	Lacrimedics, Inc.
K991130	FLEXPLUG	Apr 20, 1999	Substantially Equivalent	Eagle Vision, Inc.
K980844	SURGIDEV SILICONE PUNCTUM PLUG	May 11, 1998	Substantially Equivalent	Advanced Vision Science
K980437	SILICONE PUNCTAL PLUG	Apr 30, 1998	Substantially Equivalent	Oasis Medical, Inc.
K972523	PUNCTUAL OCCLUDER	Sep 09, 1997	Substantially Equivalent	Odyssey Medical, Inc.
K970631	PUNCTUAL OCCLUDER	Apr 23, 1997	Substantially Equivalent	Odyssey Medical, Inc.
K963708	HERRICK ULTIMATE PUNCTUM PLUG	Apr 14, 1997	Substantially Equivalent	Lacrimedics, Inc.
K963501	HERRICK ULTIMATE PUNCTUM PLUG	Apr 14, 1997	Substantially Equivalent	Lacrimedics, Inc.
K964774	PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS	Dec 20, 1996	Substantially Equivalent	Fci Ophthalmics, Inc.
K961909	READY-SET PUNCTAL PLUGS	Jul 25, 1996	Substantially Equivalent	Fci Ophthalmics, Inc.
K953394	VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}	Oct 12, 1995	Substantially Equivalent	Visitec Co.
K954094	OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)	Oct 05, 1995	Substantially Equivalent	G.W.B. Intl., Ltd.
K950569	OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}	Mar 14, 1995	Substantially Equivalent	G.W.B. Intl., Ltd.
K946357	COLLAGEN INTRACANALICULAR PLUG	Feb 07, 1995	Substantially Equivalent	Oasis Medical, Inc.
K945906	SILICONE PUNCTAL PLUG	Jan 03, 1995	Substantially Equivalent	Oasis Medical, Inc.
K915809	VISITEC CANALICULAR STENT	Feb 24, 1992	Substantially Equivalent	Visitec Co.
K905427	EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG	Jun 06, 1991	Substantially Equivalent	Eagle Vision, Inc.
K911108	OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS	May 13, 1991	Substantially Equivalent	G.W.B. Intl., Ltd.
K905750	LACRIMAL PLUG	Mar 14, 1991	Substantially Equivalent	Tamcenan Corp.
K897190	LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT	Mar 28, 1990	Substantially Equivalent	Look, Inc.
K896175	HERRICK LACRIMAL PLUG TM.	Jan 22, 1990	Substantially Equivalent	Lacrimedics, Inc.
K895342	COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST	Nov 02, 1989	Substantially Equivalent	Lacrimedics, Inc.
K890714	LACRIMAL EFFICIENCY TEST (TM)	May 17, 1989	Substantially Equivalent	Lacrimedics, Inc.
K890919	TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT	May 16, 1989	Substantially Equivalent	Eagle Vision, Inc.
K890920	EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE	Apr 11, 1989	Substantially Equivalent	Eagle Vision, Inc.