The following data is part of a premarket notification filed by Wontech with the FDA for Hair Boom 69.
| Device ID | K182562 |
| 510k Number | K182562 |
| Device Name: | Hair Boom 69 |
| Classification | Laser, Comb, Hair |
| Applicant | WonTech 64 Techno 8-ro, Yuseong-gu Daejeon, KR 305-500 |
| Contact | Gyuri (erin) Park |
| Correspondent | Raymond R. Blanche NST Consultants, Inc. 642 Shunpike Road, Suite 311 Chatham, NJ 07928 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-18 |
| Decision Date | 2018-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800022300674 | K182562 | 000 |