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Greenlight Guru founder Jon Speer weighed in on the topic during an interview with The Verge, Class I and Class II products are lower-risk products, a classic Class I example is something like a tongue depressor and its much easier to get clearance than approval. Take the Apple Watch for example, which has garnered a lot of media attention for achieving FDA clearance as a Class II medical device
"BPC 157 and angiogenesis: The potential of promoting new blood vessel formation in injury repair." Annals of Anatomy , 196(6), 376383
Synthetic DNA-based swimmers driven by enzyme catalysis
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