K162489 is an FDA 510(k) clearance for the RED Light Device. This device is classified as a Light Based Over The Counter Wrinkle Reduction (Class II - Special Controls, product code OHS).
Submitted by Zhongshan Bisen Plastic Electronic Products Co., Ltd. (Zhong Shan, CN). The FDA issued a Cleared decision on January 13, 2017, 128 days after receiving the submission on September 7, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided..
| 510(k) Number | K162489 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2016 |
| Decision Date | January 13, 2017 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OHS - Light Based Over The Counter Wrinkle Reduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided. |