K223882 is an FDA 510(k) clearance for the Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02). This device is classified as a Light, Ultraviolet, Dermatological (Class II - Special Controls, product code FTC).
Submitted by Shenzhen Honpal Optoelectronic Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 27, 2023, 90 days after receiving the submission on December 27, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K223882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2022 |
| Decision Date | March 27, 2023 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTC - Light, Ultraviolet, Dermatological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4630 |