Optical Markers/Fixation Ring/Cannu & Irriga Cannu
FDA 510(k) K861535 · CooperVision, Inc.
510(k) numberK861535
Submission
- Device name
- Optical Markers/Fixation Ring/Cannu & Irriga Cannu
- Applicant
- CooperVision, Inc.
Bellevue, WA, US - Received
- April 24, 1986
- Decision date
- May 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMR – Marker, Ocular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4570
- Specialty
- Ophthalmic
Other 510(k)s with product code HMR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053475 | Optipoint Corneal Marker, Model VPT-OPT-450HMR · Traditional | Refractec, Inc. | 03/03/2006SE |
| K925606 | Optical Zone/Hexagonal/Astigmatism/Radial MarkersHMR · Traditional | Chiron Vision Corp. | 08/29/1994SE |
| K872747 | Laser Centering DeviceHMR · Traditional | Innomed Corp. | 09/04/1987SE |
| K863663 | Ophthalmic Surgical Ocular MarkersHMR · Traditional | Myocure, Inc. | 10/20/1986SE |
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| 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 Optical Markers/Fixation Ring/Cannu & Irriga Cannu cleared by the FDA?
Optical Markers/Fixation Ring/Cannu & Irriga Cannu (K861535) received a 510(k) decision of Substantially Equivalent on May 14, 1986, 20 days after the submission was received.
What is the product code of K861535?
The FDA product code is HMR – Marker, Ocular, a Class I (low risk) device regulated under 21 CFR 886.4570.