Optos Advance
FDA 510(k) K113696 · Optos Plc.
510(k) numberK113696
Submission
- Device name
- Optos Advance
- Applicant
- Optos Plc.
Washington, DC, US - Received
- December 16, 2011
- Decision date
- May 25, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K142897 | P200DTxMYC · Traditional | 01/16/2015SE |
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| K121043 | Optos Oct/Slo MicroperimeterOBO · Traditional | 02/22/2013SE |
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Questions and answers
When was Optos Advance cleared by the FDA?
Optos Advance (K113696) received a 510(k) decision of Substantially Equivalent on May 25, 2012, 161 days after the submission was received.
What is the product code of K113696?
The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.