The following data is part of a premarket notification filed by Ulike Co., Ltd with the FDA for Diamond Air+ (ui04a, Ui04b, Ui04c).
| Device ID | K221553 |
| 510k Number | K221553 |
| Device Name: | Diamond Air+ (UI04A, UI04B, UI04C) |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Ulike Co., Ltd 2, Myeongdong, 6-gil, Jung-gu Seoul, KR 04535 |
| Contact | Lin Xiaoming |
| Correspondent | Sun Cindy PureVision Ai, Inc. 111 Town Square Place, Suite 1203 New Jersey, NJ 07310 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-31 |
| Decision Date | 2022-09-15 |