SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
FDA 510(k) K213988 · Oasis Medical, Inc.
510(k) numberK213988
Submission
- Device name
- SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
- Applicant
- Oasis Medical, Inc.
Glendora, CA, US - Received
- December 20, 2021
- Decision date
- June 3, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZU – Plug, Punctum
- Device class
- Unclassified
Other 510(k)s with product code LZU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241229 | Hello,eyes® BIO PlugLZU · Traditional | Bio Optics Co., Ltd. | 06/28/2024SE |
| K222164 | Visant Medical Canalicular PlugLZU · Traditional | Visant Medical, Inc. | 12/23/2022SE |
| K190210 | Tear Pool Dissolvable Punctum PlugsLZU · Traditional | Alphamed, Inc. | 10/24/2019SE |
| K162361 | Soft Plug Extended Duration 180 Canalicular PlugLZU · Traditional | Oasis Medical, Inc. | 04/17/2017SE |
| K161673 | LacriPro Punctum PlugLZU · Traditional | Lacrimedics, Inc. | 11/18/2016SE |
| K150288 | PDO Absorbable Punctum PlugLZU · Traditional | Riverpoint Medical | 08/28/2015SE |
| K140352 | VeraplugLZU · Traditional | Krishna Imports Inc Dba Stephens Instruments | 11/13/2014SE |
| K140711 | Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum Plug…LZU · Traditional | Paragon Bioteck, Inc. | 06/20/2014SE |
| K140026 | Collasyn Plug for the Lacrimal Efficiency TestLZU · Traditional | Lacrimedics, Inc. | 06/03/2014SE |
| K090938 | Flow ControllerLZU · Traditional | Odyssey Medical, Inc. | 06/04/2009SE |
More from Odyssey Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K162361 | Soft Plug Extended Duration 180 Canalicular PlugLZU · Traditional | 04/17/2017SE |
| K032297 | Disposable N-Pe Mickrokeratome BladesHNO · Special | 08/26/2003SE |
| K030401 | Disposable M2-PE Microkeratome BladesHNO · Traditional | 06/19/2003SE |
| K022205 | Disposable N-Pe Microkeratome BladesHNO · Traditional | 10/03/2002SE |
| K013613 | Soft Plug Absorbable Plug-SaLZU · Traditional | 06/27/2002SE |
| K003820 | Disposable Cb-Pe Microkeratome BladesHNO · Traditional | 03/08/2001SE |
| K001176 | Disposable Microkeratome Blades-PeHNO · Traditional | 09/21/2000SE |
| K980437 | Silicone Punctal PlugLZU · Traditional | 04/30/1998SE |
| K950798 | Posterior Capsule ShieldHQC · Traditional | 05/22/1995SE |
| K950241 | Ophthalmic SpongesHOZ · Traditional | 02/27/1995SE |
Questions and answers
When was SOFT PLUG Extended Duration 180 Tapered Canalicular Plug cleared by the FDA?
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (K213988) received a 510(k) decision of Substantially Equivalent on June 3, 2022, 165 days after the submission was received.
What is the product code of K213988?
The FDA product code is LZU – Plug, Punctum, a Unclassified device.