P200MAAF
FDA 510(k) K102492 · Optos Plc.
510(k) numberK102492
Submission
- Device name
- P200MAAF
- Applicant
- Optos Plc.
Washington, DC, US - Received
- August 31, 2010
- Decision date
- September 30, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K192113 | DRSplusMYC · Traditional | Centervue S.P.A. | 11/15/2019SE |
| 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 |
More from Centervue S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K233602 | P200TE (A10700)OBO · Traditional | 05/09/2024SE |
| K231673 | P200TE (A10700)OBO · Traditional | 08/18/2023SE |
| K190732 | P200TxEOBO · Traditional | 07/31/2019SE |
| K173707 | P200TEOBO · Traditional | 02/28/2018SE |
| K162039 | OptosAdvance 4.0 SoftwareNFJ · Traditional | 02/08/2017SE |
| K142897 | P200DTxMYC · Traditional | 01/16/2015SE |
| K134039 | Daytona Icg (P200TICG)MYC · Traditional | 04/11/2014SE |
| K121043 | Optos Oct/Slo MicroperimeterOBO · Traditional | 02/22/2013SE |
| K113696 | Optos AdvanceNFJ · Traditional | 05/25/2012SE |
| K111628 | P200TMYC · Special | 08/19/2011SE |
Questions and answers
When was P200MAAF cleared by the FDA?
P200MAAF (K102492) received a 510(k) decision of Substantially Equivalent on September 30, 2010, 30 days after the submission was received.
What is the product code of K102492?
The FDA product code is MYC – Ophthalmoscope, Laser, Scanning, a Class II (moderate risk) device regulated under 21 CFR 886.1570.