510(k) K140711
- Device
- COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
- Applicant
- PARAGON BIOTECK, INC.
- 510(k) number
- K140711
- Product code
- LZU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-06-20
- Date received
- 2014-03-21
- Regulation
- 510(k) Premarket Notification
- Classification name
- Plug, Punctum
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ophthalmic
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAUREN M-C BLUETT
- Address
- 4640 SW Macadam, Suite 80 Portland OR US 97239 97239
FDA Registration Numbers#
- 3006234743
- 3010692967
- 3003672980
- 2245304
- 1225124
- 2031959
- 1047843
- 3031056804
- 3010487482
- 2011171
- 1649518
- 3011965331
- 3017609685
- 3002907620
- 2083373
- 3030244488
- 1226074
- 3013421458
- 2029275
- 3010162973
- 3008719017
- 2242450
- 1211998
- 9615745
- 1319660
- 1643817
- 3004467263
- 2030624
- 3013466775
- 3006981798
- 2032098
- 1000286794
- 3015177648
- 3002991496
- 1641445
- 1045379
- 2183744
- 2031962
Source Documents#
Other 510(k) Records For Product Code LZU #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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