Clerz Lubricating/Rewetting Solution
FDA 510(k) K833494 · CooperVision, Inc.
510(k) numberK833494
Submission
- Device name
- Clerz Lubricating/Rewetting Solution
- Applicant
- CooperVision, Inc.
Southampton, GB - Received
- October 7, 1983
- Decision date
- January 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HKX – Tonometer, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
Other 510(k)s with product code HKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253039 | Auto Kerato-Refracto Tonometer TRK-3 OmniaHKX · Traditional | Topcon Corporation | 11/07/2025SE |
| K223739 | VS Tabletop TonometerHKX · Traditional | Medimaging Integrated Solution, Inc. | 11/08/2023SE |
| K190382 | Intraocular Pressure Tonometer EASYTONHKX · Traditional | Company Elamed | 12/06/2019SE |
| K181260 | MiiS Horus Scope DPT 100HKX · Traditional | Medimaging Integrated Solution, Inc (Miis) | 06/21/2019SE |
| K181143 | Keeler TonoCare TonometerHKX · Traditional | Keeler Instruments, Inc. | 02/08/2019SE |
| K180820 | Tono Vue Non-Contact TonometerHKX · Traditional | Crystalvue Medical Corporation | 12/14/2018SE |
| K162067 | VX130 Ophthalmic Diagnostic DeviceHKX · Traditional | Luneau Sas | 04/24/2017SE |
| K143086 | VX120 Ophthalmic Diagnostic DeviceHKX · Traditional | Luneau Sas | 06/01/2015SE |
| K113066 | Corvis STHKX · Traditional | Oculus Optikgerate GmbH | 11/08/2012SE |
| K111710 | Full Auto Tonometer Model TX-20HKX · Special | Canon Inc. -Medical Equipment Group | 09/20/2011SE |
More from Canon Inc. -Medical Equipment Group
| 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 Clerz Lubricating/Rewetting Solution cleared by the FDA?
Clerz Lubricating/Rewetting Solution (K833494) received a 510(k) decision of Substantially Equivalent on January 4, 1984, 89 days after the submission was received.
What is the product code of K833494?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.