Poly Clear
Over-the-counter Powered Light Based Laser For Acne
Medtek Skincare, LLC
The following data is part of a premarket notification filed by Medtek Skincare, Llc with the FDA for Poly Clear.
Pre-market Notification Details
| Device ID | K183708 |
| 510k Number | K183708 |
| Device Name: | Poly Clear |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Medtek Skincare, LLC 3 Depot Street Hudson Falls, NY 12839 |
| Contact | Gary Richardson |
| Correspondent | Susan Anthony-dewet FDA Regulatory Consultants, LLC 1604 NE 4th CT Ft. Lauderdale, FL 33301 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-31 |
| Decision Date | 2019-09-17 |
| Summary: | summary |
Trademark Results [Poly Clear]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLY CLEAR 78595557 not registered Indifferent |
sun, david 0000-00-00 |
 POLY CLEAR 77871130 3854900 Dead/Cancelled |
Hero Arts Rubber Stamps, Inc. 2009-11-12 |
 POLY CLEAR 77111517 not registered Dead/Abandoned |
Prime Products, Inc. 2007-02-20 |
 POLY CLEAR 74233484 1799376 Dead/Cancelled |
Thermo Plastics Display, Inc. 1991-12-26 |
 POLY CLEAR 73839415 1607863 Dead/Cancelled |
VUE-ALL, INC. 1989-11-15 |
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