A
Hello All,
We have a new laser wavelength for a class 2 aesthetic product that we are submitting 510k. Our device is the same laser classification but approximately 20nm from the predicate devices' center wavelength, however we have not completed patient studies, which the predicate did complete.
We justify our substantial equivalence by listing the predicates' studies results and one study for a product that was not FDA cleared.
1. should we exclude the study for the device that was not FDA cleared?
2. should we go into limited/extensive technical discussion for how our wavelength has equivalent efficacy, with citations to studies and research.
there is extensive research unfortunately not single landmark study, so painting a clear technical justification is a bit messy. How much detail do they like/want/need is the question for this approach
3. should we just mention it as a nominal difference and make a simple claim and more on?
4. should we expect it to bounce back with "need clinical studies" because of the vary fact that the predicate had clinical studies?
warm regards
We have a new laser wavelength for a class 2 aesthetic product that we are submitting 510k. Our device is the same laser classification but approximately 20nm from the predicate devices' center wavelength, however we have not completed patient studies, which the predicate did complete.
We justify our substantial equivalence by listing the predicates' studies results and one study for a product that was not FDA cleared.
1. should we exclude the study for the device that was not FDA cleared?
2. should we go into limited/extensive technical discussion for how our wavelength has equivalent efficacy, with citations to studies and research.
there is extensive research unfortunately not single landmark study, so painting a clear technical justification is a bit messy. How much detail do they like/want/need is the question for this approach
3. should we just mention it as a nominal difference and make a simple claim and more on?
4. should we expect it to bounce back with "need clinical studies" because of the vary fact that the predicate had clinical studies?
warm regards