The following data is part of a premarket notification filed by Chongqing Peninsula Medical Technology Co., Ltd. with the FDA for Irradiation Aesthetic Device.
| Device ID | K171835 |
| 510k Number | K171835 |
| Device Name: | Irradiation Aesthetic Device |
| Classification | Laser, Comb, Hair |
| Applicant | Chongqing Peninsula Medical Technology Co., Ltd. No.2-4, 2F BLK1, Biological And Biochemical Park 70-1 & 70-2# Ke Yuan 4 RD Jiulongpo District, CN 404100 |
| Contact | Zhang Sudi |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion No.121 Science Road, Guangzhou Science Park Guangzhou, CN 51006 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-20 |
| Decision Date | 2018-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971777450029 | K171835 | 000 |