The following data is part of a premarket notification filed by Heat In A Click Llc with the FDA for Looper (model: Zx-579s).
| Device ID | K202055 |
| 510k Number | K202055 |
| Device Name: | Looper (Model: ZX-579S) |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Heat In A Click LLC 1975 Tigertail Blvd Dania Homestead, FL 33034 |
| Contact | Guy Levi |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510006 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-24 |
| Decision Date | 2021-04-16 |