Hi Laura:
Several clarifications which may (or may not) be what senior management desired:
FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always and for OTC use ever since the mid 2000's. My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.
Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.
FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this. Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC clearance.
Happy to discuss further hope this helps!
Glen
------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com------------------------------
Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices
Hi Colleagues,
I have a device that we are trying to launch in the US that has no currently marketed predicate. FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated. It is to be inserted in the vagina and has LED as an energy source.
I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?
I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated.
Please advise.
Laura