Collagen Implants for the Lacrimal Efficiency Test
FDA 510(k) K895342 · Lacrimedics, Inc.
510(k) numberK895342
Submission
- Device name
- Collagen Implants for the Lacrimal Efficiency Test
- Applicant
- Lacrimedics, Inc.
Rosemead, CA, US - Received
- August 31, 1989
- Decision date
- November 2, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Lacrimedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K161673 | LacriPro Punctum PlugLZU · Traditional | 11/18/2016SE |
| K140026 | Collasyn Plug for the Lacrimal Efficiency TestLZU · Traditional | 06/03/2014SE |
| K030300 | Opaque Herrick Lacrimal PlugLZU · Traditional | 05/09/2003SE |
| K021831 | Opaque Herrick Lacrimal Plug, 0.3MM,0.5MM,0.7MM, Models HLP3-OPB,HLP50OPB,HLP7-OPBLZU · Special | 07/01/2002SE |
| K001737 | Opaque Herrick Plug, 0.3MM; 0.5MM; O.7MMLZU · Special | 06/19/2000SE |
| K963708 | Herrick Ultimate Punctum PlugLZU · Traditional | 04/14/1997SE |
| K963501 | Herrick Ultimate Punctum PlugLZU · Traditional | 04/14/1997SE |
| K944402 | FocometerHLJ · Traditional | 11/22/1994SE |
| K896175 | Herrick Lacrimal Plug Tm.LZU · Traditional | 01/22/1990SE |
| K890714 | Lacrimal Efficiency Test (TM)LZU · Traditional | 05/17/1989SE |
Questions and answers
When was Collagen Implants for the Lacrimal Efficiency Test cleared by the FDA?
Collagen Implants for the Lacrimal Efficiency Test (K895342) received a 510(k) decision of Substantially Equivalent on November 2, 1989, 63 days after the submission was received.
What is the product code of K895342?
The FDA product code is LZU – Plug, Punctum, a Unclassified device.