The following data is part of a premarket notification filed by Hunan Guangye Biotechnology Co., Ltd. with the FDA for Ipl Hair Removal Device, Model(s): Kca423, Kca437, Kca439.
| Device ID | K222432 |
| 510k Number | K222432 |
| Device Name: | IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Hunan Guangye Biotechnology Co., Ltd. Room A701, Jinhong Park Incubation Building, No.229, Tongzipo West Road, High-tech Development Changsha City, CN 410006 |
| Contact | Eileen Li |
| Correspondent | Tracy Che Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, CN 518052 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-12 |
| Decision Date | 2022-10-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975587680034 | K222432 | 000 |