The following data is part of a premarket notification filed by Glan Electronics Co., Ltd. with the FDA for Ipl Hair Removal, Model: Obt-02.
| Device ID | K213041 |
| 510k Number | K213041 |
| Device Name: | IPL Hair Removal, Model: OBT-02 |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Glan Electronics Co., Ltd. A4 Building, Huafa Industrial Zone, Fuyuan 1st Road, Xinhe Community, Fuyong Town, Bao'an Dist Shenzhen, CN |
| Contact | Lisa Pan |
| Correspondent | Iris Fung SGS-CSTC Standards Technical Services Co., LTD 198 Kezhu Road, ScienTech Park Guangzhou Economic & Tech Development District Guangzhou, CN |
| Product Code | OHT |
| 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 | 2021-11-18 |