The following data is part of a premarket notification filed by Marci Beauty Inc with the FDA for Infrared Red Blue Led Light Heat Beauty Machine, Infrared Red Blue Led Light Heat Beauty Machine, Infrared Red Blue Led Light Heat Beauty Machine.
| Device ID | K210545 |
| 510k Number | K210545 |
| Device Name: | Infrared Red Blue LED Light Heat Beauty Machine, Infrared Red Blue LED Light Heat Beauty Machine, Infrared Red Blue LED Light Heat Beauty Machine |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Marci Beauty Inc 4290 Cameron St Unit 7 Las Vegas, NV 89103 |
| Contact | Shaul Rappaport |
| Correspondent | Helen Nan Wenzhou Cytech Information Service Co., Ltd. Room302, Building 3, Hangqian Mansion, Hanqian Street, Lucheng District Wenzhou, CN 325000 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-25 |
| Decision Date | 2022-05-20 |