The following data is part of a premarket notification filed by Esthetic Education Llc with the FDA for Skinstylus Sterilock Microsystem.
| Device ID | K200044 |
| 510k Number | K200044 |
| Device Name: | SkinStylus SteriLock MicroSystem |
| Classification | Powered Microneedle Device |
| Applicant | Esthetic Education LLC 7950 E. Acoma Drive Suite 100 Scottsdale, AZ 85260 |
| Contact | Marc C. Sanchez |
| Correspondent | Marc C. Sanchez Contract In-House Counsel And Consultants, LLC (d/b/a FDA Atty) 53516 Bickett Chapel Hill, NC 27517 |
| Product Code | QAI |
| CFR Regulation Number | 878.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-08 |
| Decision Date | 2020-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00196852554485 | K200044 | 000 |