The following data is part of a premarket notification filed by Shenzhen Osto Technology Company Limited with the FDA for Led Facial Mask.
| Device ID | K213056 |
| 510k Number | K213056 |
| Device Name: | LED Facial Mask |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Shenzhen OSTO Technology Company Limited No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District Shenzhen, CN 518100 |
| Contact | Li Yang |
| Correspondent | Jett Lee Guangdong Jianda Medical Technology Co Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou, CN |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-22 |
| Decision Date | 2022-07-07 |