K151336 is an FDA 510(k) clearance for the LightStim Professional 2-Panel Light. This device is classified as a Light Based Over The Counter Wrinkle Reduction (Class II - Special Controls, product code OHS).
Submitted by Led Intellectual Properties, LLC (Irvine, US). The FDA issued a Cleared decision on October 23, 2015, 157 days after receiving the submission on May 19, 2015.
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 | K151336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2015 |
| Decision Date | October 23, 2015 |
| Days to Decision | 157 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. |