DRSplus
FDA 510(k) K192113 · Centervue S.P.A.
510(k) numberK192113
Submission
- Device name
- DRSplus
- Applicant
- Centervue S.P.A.
Padova, IT - Received
- August 5, 2019
- Decision date
- November 15, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYC – Ophthalmoscope, Laser, Scanning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
Other 510(k)s with product code MYC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261255 | Kowa FM-600MYC · Traditional | Kowa Company, Ltd. Chofu Factory | 09/11/2026SE |
| K241931 | OcuMet Beacon (OCUB100)MYC · Traditional | Ocusciences, Inc. | 04/22/2025SE |
| K243504 | Maia (AHMACME001)MYC · Traditional | Centervue S.P.A. | 03/17/2025SE |
| K213705 | DRSplusMYC · Special | Centervue S.P.A. | 12/21/2021SE |
| K211328 | Eidon Fa, Eidon, Eidon Af, Eidon UwflMYC · Special | Centervue S.P.A. | 08/19/2021SE |
| K180526 | Eidon FaMYC · Traditional | Centervue S.P.A. | 07/16/2018SE |
| K180293 | Retia 2MYC · Traditional | Centervue S.P.A. | 05/30/2018SE |
| K153181 | MaiaMYC · Traditional | Centervue S.P.A. | 06/08/2016SE |
| K150320 | CompassMYC · Traditional | Centervue S.P.A. | 06/30/2015SE |
| K142897 | P200DTxMYC · Traditional | Optos Plc. | 01/16/2015SE |
More from Optos Plc.
| 510(k) | Device | Decision |
|---|---|---|
| K243504 | Maia (AHMACME001)MYC · Traditional | 03/17/2025SE |
| K234076 | iCare ALTIUS CWNFJ · Traditional | 08/22/2024SE |
| K213705 | DRSplusMYC · Special | 12/21/2021SE |
| K211328 | Eidon Fa, Eidon, Eidon Af, Eidon UwflMYC · Special | 08/19/2021SE |
| K180526 | Eidon FaMYC · Traditional | 07/16/2018SE |
| K180293 | Retia 2MYC · Traditional | 05/30/2018SE |
| K153181 | MaiaMYC · Traditional | 06/08/2016SE |
| K150320 | CompassMYC · Traditional | 06/30/2015SE |
| K142047 | EidonMYC · Traditional | 11/12/2014SE |
| K133758 | Centervue Macular Integrity AssessmentHLI · Traditional | 04/23/2014SE |
Questions and answers
When was DRSplus cleared by the FDA?
DRSplus (K192113) received a 510(k) decision of Substantially Equivalent on November 15, 2019, 102 days after the submission was received.
What is the product code of K192113?
The FDA product code is MYC – Ophthalmoscope, Laser, Scanning, a Class II (moderate risk) device regulated under 21 CFR 886.1570.