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Category: Legal
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We are planning on launching an ophthalmic disposable

Customer Question

We are planning on launching an ophthalmic disposable endoscope and reusable laser camera, would these require a 510k please?
Submitted: 1 year ago.
Category: Legal
Expert:  MyVirtualCPA replied 1 year ago.

In this situation, a 510K would be required. Among other times, it's required "

  1. Introducing a device into commercial distribution (marketing) for the first time. After May 28, 1976 (effective date of the Medical Device Amendments to the Act), anyone who wants to sell a device in the U.S. is required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date. If your device was not marketed by your firm before May 28, 1976, a 510(k) is required.

For more information, please look here:

Please let me know if you need anything additional. If not, please rate positive.

Customer: replied 1 year ago.

I understand this Megan, however that is not true in every situation. what about predicate devices that already exist in the market in regards ***** ***** endoscope and reusable camera?

Expert:  MyVirtualCPA replied 1 year ago.

You will still need to fill out the disclosure indicating that the device is safe.

Expert:  Briarcliff767 replied 1 year ago.

Hi, my name is ***** ***** I am happy to assist you. I have dealt with many companies getting their devices classified and through the pre market process. Your devices could be classified as a Class I which will not need to have a 501K. I have a personal contact with the FDA classification department and here is the email that you should send your request to listing your exact device and they will reach out most likely tomorrow since it is past 5 pm est.***@******.***. Please note that I am not your previous expert and please let me know if you would like me to assist you with getting pre market approval or classification of the devices. Thank you Hope