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)…

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510(k) Transfer of Ownership

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…

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New FDA Expedited Access Pathway Program

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FDA Regulation of Personal Lubricants

FDA Regulation of Personal Lubricants –

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Shutdown Delays Medical Device Approvals (510(k)s)

As the shutdown continues the impact continues to be felt.

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