The following data is part of a premarket notification filed by Heat In A Click with the FDA for 2 Face / Face Evolution.
| Device ID | K171821 |
| 510k Number | K171821 |
| Device Name: | 2 Face / Face Evolution |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Heat In A Click 1975 Tigertail Blvd Dania Homestead, FL 33034 |
| Contact | Guy Levi |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, CN 510006 |
| Product Code | NFO |
| Subsequent Product Code | OHS |
| Subsequent Product Code | OLP |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-19 |
| Decision Date | 2018-04-26 |
| Summary: | summary |