The following data is part of a premarket notification filed by Medtek Skincare, Llc with the FDA for Poly Rejuv.
| Device ID | K180875 |
| 510k Number | K180875 |
| Device Name: | POLY REJUV |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Medtek Skincare, LLC 3 Depot Street Hudson Falls, NY 12839 |
| Contact | Gary Richardson |
| Correspondent | Susan Anthoney-dewet Aegis Regulatory, Inc. 2424 Dempster Drive Coralville, IA 52241 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-03 |
| Decision Date | 2018-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3437000A2 | K180875 | 000 |