MEDICAL
Microneedling FDA Clearance
Microneedling FDA Clearance has been granted to Esthetic Education LLC for its SkinStylus SteriLock MicroSystem (K200044). Esthetic Education is among the very first microneedling 510(k)…
510(k) Transfer of Ownership
A 510(k) for a medical device can be thought of as like a patent making a 510(k) transfer of ownership, say following a sale, for…
Shutdown Delays Medical Device Approvals (510(k)s)
As the shutdown continues the impact continues to be felt.