Ophta Sil {Self-Threading Monoka (Ritleng Type)}
FDA 510(k) K950569 · G.W.B. Intl., Ltd.
510(k) numberK950569
Submission
- Device name
- Ophta Sil {Self-Threading Monoka (Ritleng Type)}
- Applicant
- G.W.B. Intl., Ltd.
Marshfield, MA, US - Received
- February 1, 1995
- Decision date
- March 14, 1995
- 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 |
More from Lacrimedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955671 | Ritleng Bican.Lacr.Sets/Self Thread. Monokas(Chg.In Ster.)OKS · Traditional | 03/06/1996SE |
| K954094 | Ophta Sil- Punctal Plugs (Modification)LZU · Traditional | 10/05/1995SE |
| K940508 | Ophta Sil (Ritleng Probe and Lacrimal Intubation Set)OKS · Traditional | 05/04/1994SE |
| K911110 | Ophta Sil(R), Enulceation/Evisceration ImplantsHPZ · Traditional | 06/18/1991SE |
| K911108 | Ophta Sil (R), Punctal Plugs and InsertersLZU · Traditional | 05/13/1991SE |
| K911109 | Ophta Sil (R), Lachrymal Intubation SetsOKS · Traditional | 05/01/1991SE |
| K896029 | Digital Ultrasound Imaging System Dub 20IYO · Traditional | 01/12/1990SE |
Questions and answers
When was Ophta Sil {Self-Threading Monoka (Ritleng Type)} cleared by the FDA?
Ophta Sil {Self-Threading Monoka (Ritleng Type)} (K950569) received a 510(k) decision of Substantially Equivalent on March 14, 1995, 41 days after the submission was received.
What is the product code of K950569?
The FDA product code is LZU – Plug, Punctum, a Unclassified device.