Product code LZU
- Device name
- Plug, Punctum
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241229 | Hello,eyes® BIO Plug | Bio Optics Co., Ltd. | 2024-06-28 |
| K222164 | Visant Medical Canalicular Plug | Visant Medical, Inc. | 2022-12-23 |
| K213988 | SOFT PLUG Extended Duration 180 Tapered Canalicular Plug | Oasis Medical, Inc. | 2022-06-03 |
| K190210 | Tear Pool Dissolvable Punctum Plugs | Alphamed, Inc. | 2019-10-24 |
| K162361 | Soft Plug Extended Duration 180 Canalicular Plug | Oasis Medical, Inc. | 2017-04-17 |
| K161673 | LacriPro Punctum Plug | Lacrimedics, Inc. | 2016-11-18 |
| K150288 | PDO Absorbable Punctum Plug | Riverpoint Medical | 2015-08-28 |
| K140352 | VERAPLUG | Krishna Imports Inc Dba Stephens Instruments | 2014-11-13 |
| K140711 | COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG, | Paragon Bioteck, Inc. | 2014-06-20 |
| K140026 | COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST | Lacrimedics, Inc. | 2014-06-03 |
| K090938 | FLOW CONTROLLER | Odyssey Medical, Inc. | 2009-06-04 |
| K061398 | SNUG PLUG PUNCTUM PLUG | Fci Ophthalmics, Inc. | 2006-07-11 |
| K053333 | EAGLEVISION GELLANSERTS, MODEL REF 0040 | Eagle Vision, Inc. | 2006-05-02 |
| K050851 | DELTA PUNCTUM PLUG | Delta Life Science, Inc. | 2005-08-19 |
| K040912 | HYDROGEL CANALICULAR PLUG | Partners IN Biomaterials, Inc. | 2004-11-16 |
| K040231 | INTELIPORT OCCLUDING DEVICE | Alcon, Inc. | 2004-07-13 |
| K030300 | OPAQUE HERRICK LACRIMAL PLUG | Lacrimedics, Inc. | 2003-05-09 |
| K022043 | SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503 | Medennium, Inc. | 2002-10-18 |
| K021936 | MOIST PUNCTAL PLUG SYSTEM | Moist Medical, Inc. | 2002-10-16 |
| K020882 | SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG | Surgical Specialties Corp | 2002-07-26 |
| K021831 | OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB | Lacrimedics, Inc. | 2002-07-01 |
| K013613 | SOFT PLUG ABSORBABLE PLUG-SA | Oasis Medical, Inc. | 2002-06-27 |
| K001768 | OCCU-FLO PUNCTUM PLUGS | U.S. Iol, Inc. | 2000-09-19 |
| K001234 | BIOINSULATED SILICONE PUNCTUM PLUG | Advanced Vision Science | 2000-07-11 |
| K001737 | OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM | Lacrimedics, Inc. | 2000-06-19 |
| K991130 | FLEXPLUG | Eagle Vision, Inc. | 1999-04-20 |
| K980844 | SURGIDEV SILICONE PUNCTUM PLUG | Advanced Vision Science | 1998-05-11 |
| K980437 | SILICONE PUNCTAL PLUG | Oasis Medical, Inc. | 1998-04-30 |
| K972523 | PUNCTUAL OCCLUDER | Odyssey Medical, Inc. | 1997-09-09 |
| K970631 | PUNCTUAL OCCLUDER | Odyssey Medical, Inc. | 1997-04-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 13700773734808 | TearSaver® - 0.8 mm | FCI S A S FCI 20 22 | 2023-11-13 |
| 13700773734761 | TearSaver® - 0.4 mm | FCI S A S FCI 20 22 | 2023-11-13 |
| 13700773734778 | TearSaver® - 0.5 mm | FCI S A S FCI 20 22 | 2023-11-13 |
| 13700773734785 | TearSaver® - 0.6 mm | FCI S A S FCI 20 22 | 2023-11-13 |
| 13700773734792 | TearSaver® - 0.7 mm | FCI S A S FCI 20 22 | 2023-11-13 |
| 10845819000097 | SOFT PLUG® Silicone Punctum Plug | OASIS MEDICAL, INC. | 2023-06-30 |
| 10845819000110 | SOFT PLUG® Silicone Punctum Plug | OASIS MEDICAL, INC. | 2023-06-30 |
| 10845819000134 | SOFT PLUG® Silicone Punctum Plug | OASIS MEDICAL, INC. | 2023-06-30 |
| 10845819000240 | SOFT PLUG® Extended Duration Plugs | OASIS MEDICAL, INC. | 2023-06-30 |
| 10845819000257 | SOFT PLUG® Extended Duration Plugs | OASIS MEDICAL, INC. | 2023-06-30 |
| 30886158015384 | MICRO FLOW™ | Beaver-Visitec International, Inc. | 2022-02-02 |
| 30886158015322 | PARASOL® | Beaver-Visitec International, Inc. | 2022-02-02 |
| 30886158015339 | PLUS | Beaver-Visitec International, Inc. | 2022-02-02 |
| 30886158015346 | PLUS | Beaver-Visitec International, Inc. | 2022-02-02 |
| 30886158015353 | PLUS | Beaver-Visitec International, Inc. | 2022-02-02 |
| 30886158015360 | PLUS | Beaver-Visitec International, Inc. | 2022-02-02 |
| 30886158015377 | MICRO FLOW™ | Beaver-Visitec International, Inc. | 2022-02-02 |
| 30886158015315 | Parasol® | Beaver-Visitec International, Inc. | 2022-02-01 |
| 30886158015308 | PARASOL® | Beaver-Visitec International, Inc. | 2022-02-01 |
| 30886158015292 | Parasol® | Beaver-Visitec International, Inc. | 2022-02-01 |
| 30886158015247 | EXTEND™ | Beaver-Visitec International, Inc. | 2022-01-31 |
| 30886158015285 | EXTEND™ | Beaver-Visitec International, Inc. | 2022-01-31 |
| 30886158015278 | EXTEND™ | Beaver-Visitec International, Inc. | 2022-01-31 |
| 30886158015261 | EXTEND™ | Beaver-Visitec International, Inc. | 2022-01-31 |
| 30886158015254 | EXTEND™ | Beaver-Visitec International, Inc. | 2022-01-31 |
| 10810003223545 | Comfortear™ | MICROSPECIALITIES, INC. | 2019-01-03 |
| 10810003223583 | Comfortear™ | MICROSPECIALITIES, INC. | 2019-01-03 |
| 10810003223576 | Comfortear™ | MICROSPECIALITIES, INC. | 2019-01-03 |
| 10810003223569 | Comfortear™ | MICROSPECIALITIES, INC. | 2019-01-03 |
| 10810003223552 | Comfortear™ | MICROSPECIALITIES, INC. | 2019-01-03 |