Delta Punctum Plug
FDA 510(k) K050851 · Delta Life Science, Inc.
510(k) numberK050851
Submission
- Device name
- Delta Punctum Plug
- Applicant
- Delta Life Science, Inc.
Memphis, TN, US - Received
- April 4, 2005
- Decision date
- August 19, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K213988 | SOFT PLUG Extended Duration 180 Tapered Canalicular PlugLZU · Traditional | Oasis Medical, Inc. | 06/03/2022SE |
| 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 |
Questions and answers
When was Delta Punctum Plug cleared by the FDA?
Delta Punctum Plug (K050851) received a 510(k) decision of Substantially Equivalent on August 19, 2005, 137 days after the submission was received.
What is the product code of K050851?
The FDA product code is LZU – Plug, Punctum, a Unclassified device.