The following data is part of a premarket notification filed by Xuzhou Kernel Medical Equipment Co., Ltd. with the FDA for Uv Phototherapy.
| Device ID | K181805 |
| 510k Number | K181805 |
| Device Name: | UV Phototherapy |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | Xuzhou Kernel Medical Equipment Co., LTD. Kernel Mansion, Economic Development District Xuzhou, CN 221004 |
| Contact | Jing Wang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-06 |
| Decision Date | 2019-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06928798600223 | K181805 | 000 |
| 06928798600087 | K181805 | 000 |
| 06928798600094 | K181805 | 000 |
| 06928798600100 | K181805 | 000 |
| 06928798600117 | K181805 | 000 |
| 06928798600124 | K181805 | 000 |
| 06928798600131 | K181805 | 000 |
| 06928798600148 | K181805 | 000 |
| 06928798600155 | K181805 | 000 |
| 06928798600162 | K181805 | 000 |
| 06928798600179 | K181805 | 000 |
| 06928798600186 | K181805 | 000 |
| 06928798600193 | K181805 | 000 |
| 06928798600209 | K181805 | 000 |
| 06928798600216 | K181805 | 000 |
| 06928798600070 | K181805 | 000 |