The following data is part of a premarket notification filed by Chongqing Peninsula Medical Technology Co., Ltd. with the FDA for 308nm Excimer System.
| Device ID | K172273 |
| 510k Number | K172273 |
| Device Name: | 308nm Excimer System |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | Chongqing Peninsula Medical Technology Co., Ltd. No.2-4, 2F Block I, Ke Yuan 4th Road, Jiulongpo District Chongqing, CN 400041 |
| 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 510000 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-28 |
| Decision Date | 2018-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971777450036 | K172273 | 000 |