FDA 510(k) K223882, Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02), by Shenzhen Honpal Optoelectronic Technology Co., Ltd.
FDA 510(k) K223882, Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02), by Shenzhen Honpal Optoelectronic Technology Co., Ltd.
| 510(k) Number | K223882 |
| Device Classification Name | Light, Ultraviolet, Dermatological |
| Device Name | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) |
| Applicant | Shenzhen Honpal Optoelectronic Technology Co., Ltd. Rm. 505,Shenghui Bldg. A,Xixiang St.,Baoan District Shenzhen, CN 518126 |
| Regulation Number | 878.463 |
| Classification Product Code | FTC |
| Date Received | 12/27/2022 |
| Decision Date | 03/27/2023 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | General & Plastic Surgery |
| 510k Review Panel | General & Plastic Surgery |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 959 |
| Redacted Pages | 778 |
| Unredacted Pages | 181 |
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