Lensine Extra Strength Cleaner
FDA 510(k) K812433 · CooperVision, Inc.
510(k) numberK812433
Submission
- Device name
- Lensine Extra Strength Cleaner
- Applicant
- CooperVision, Inc.
Southampton, GB - Received
- August 25, 1981
- Decision date
- September 21, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPX – Lens, Contact (Polymethylmethacrylate)
- Device class
- Unclassified
Other 510(k)s with product code HPX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955777 | Pmma ClasicHPX · Traditional | Rand Scientific Corp. | 05/16/1996SE |
| K940106 | Keratoplasty Suturing LensHPX · Traditional | Visionary Technologies of Miami, Inc. | 05/25/1994SE |
| K913081 | Multi-View BifocalsHPX · Traditional | Camp Contact Lenses | 10/23/1991SE |
| K897021 | Martin-Hensley Segment LensHPX · Traditional | Bruce W. Martin O.D. and Edward Hensley | 06/22/1990SE |
| K895411 | Optikem Pmma Contact LensHPX · Traditional | Optikem Polymers, Inc. | 02/27/1990SE |
| K874591 | Illuminating Infusion Contact Lens for Eye SurgeryHPX · Traditional | Vitreo Dynamics, Co. | 05/03/1988SE |
| K865111 | Charter Hard Contact Lens Cleaning SolutionHPX · Traditional | Paco Pharmaceutical Services, Inc. | 01/20/1987SE |
| K864343 | BL1 (Hard Contact Lens)HPX · Traditional | Beta Labs, Inc. | 11/28/1986SE |
| K863974 | Charter Laboratories Inc. Lens LubricantHPX · Traditional | Paco Pharmaceutical Services, Inc. | 11/10/1986SE |
| K862952 | Charter Wetting Solution for Hard Contact LensesHPX · Traditional | Paco Pharmaceutical Services, Inc. | 09/25/1986SE |
More from Paco Pharmaceutical Services, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact…LPL · Special | 01/25/2024SE |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…LPL · Special | 02/04/2022SE |
| K213164 | Avaira VitalityLPL · Special | 10/26/2021SE |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day…LPL · Special | 10/20/2020SE |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…LPL · Traditional | 03/23/2020SE |
| K190965 | MyDayLPL · Special | 04/29/2019SE |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…LPL · Traditional | 12/11/2018SE |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensLPL · Traditional | 07/13/2016SE |
| K133627 | Avaira Spheric and Toric (Enfilcon a) Soft Contact LensLPL · Special | 12/23/2013SE |
| K131378 | Sus (Stenfilcon a) Contact LensLPL · Traditional | 08/30/2013SE |
Questions and answers
When was Lensine Extra Strength Cleaner cleared by the FDA?
Lensine Extra Strength Cleaner (K812433) received a 510(k) decision of Substantially Equivalent on September 21, 1981, 27 days after the submission was received.
What is the product code of K812433?
The FDA product code is HPX – Lens, Contact (Polymethylmethacrylate), a Unclassified device.