A
Hello,
We have a traditional 510k for class 2 device. It is an aesthetic light therapy device and there is patient contact materials which touch patient skin (healthy skin)during treatment schedule is 2x per week for 30min.
1. silicone I have a datasheet that states it is cleared for class II medical device usage. though it is not class 6 material
2. urethane foam topped with acrylic flocking and
a. does not contain levels of materials required to be reported under 29CFR 1910-1200
b. is flammable by definition in OSHA 29 CFR Hazard communications, part 1910-1200 when tested by method described in 16 CFR 1500.44
I plan to submit without getting ISO 10993 certified. These are very low risk materials, and we are unsure if predicates completed biocompability for their plastics.
I am just trying to anticipate the FDA response to this, and improve my chances much as possible if need be, what is yalls experience.
warm
regards
We have a traditional 510k for class 2 device. It is an aesthetic light therapy device and there is patient contact materials which touch patient skin (healthy skin)during treatment schedule is 2x per week for 30min.
1. silicone I have a datasheet that states it is cleared for class II medical device usage. though it is not class 6 material
2. urethane foam topped with acrylic flocking and
a. does not contain levels of materials required to be reported under 29CFR 1910-1200
b. is flammable by definition in OSHA 29 CFR Hazard communications, part 1910-1200 when tested by method described in 16 CFR 1500.44
I plan to submit without getting ISO 10993 certified. These are very low risk materials, and we are unsure if predicates completed biocompability for their plastics.
I am just trying to anticipate the FDA response to this, and improve my chances much as possible if need be, what is yalls experience.
warm
regards