COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
FDA 510(k) clearance K140711 · decided 2014-06-20
Clearance details
- K-number
- K140711
- Device name
- COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
- Applicant
- Paragon Bioteck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-03-21
- Decision date
- 2014-06-20
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- LZU
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Hello,eyes® BIO Plug (K241229) | Bio Optics Co., Ltd. | 2024-06-28 |
| Visant Medical Canalicular Plug (K222164) | Visant Medical, Inc. | 2022-12-23 |
| SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (K213988) | Oasis Medical, Inc. | 2022-06-03 |
| Tear Pool Dissolvable Punctum Plugs (K190210) | Alphamed, Inc. | 2019-10-24 |
| Soft Plug Extended Duration 180 Canalicular Plug (K162361) | Oasis Medical, Inc. | 2017-04-17 |
| LacriPro Punctum Plug (K161673) | Lacrimedics, Inc. | 2016-11-18 |
| PDO Absorbable Punctum Plug (K150288) | Riverpoint Medical | 2015-08-28 |
| VERAPLUG (K140352) | Krishna Imports Inc Dba Stephens Instruments | 2014-11-13 |
| COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (K140026) | Lacrimedics, Inc. | 2014-06-03 |
| FLOW CONTROLLER (K090938) | Odyssey Medical, Inc. | 2009-06-04 |
| SNUG PLUG PUNCTUM PLUG (K061398) | Fci Ophthalmics, Inc. | 2006-07-11 |
| EAGLEVISION GELLANSERTS, MODEL REF 0040 (K053333) | Eagle Vision, Inc. | 2006-05-02 |
Recalls involving this device
No recalls on record reference this clearance.