The following data is part of a premarket notification filed by Won Tech Co., Ltd. with the FDA for Hair Boom 69, Hair Boom Air, Ulike Hair Upup.
| Device ID | K192425 |
| 510k Number | K192425 |
| Device Name: | Hair Boom 69, Hair Boom Air, Ulike Hair UpUp |
| Classification | Laser, Comb, Hair |
| Applicant | Won Tech Co., Ltd. 64 Techno 8-Ro, Yuseong-gu Daejeon, KR 34028 |
| Contact | Jake Yu |
| Correspondent | Jake Yu Won Tech Co., Ltd. 64 Techno 8-Ro, Yuseong-gu Daejeon, KR 34028 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-05 |
| Decision Date | 2019-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800022304924 | K192425 | 000 |