The following data is part of a premarket notification filed by Pharos Life Corporation with the FDA for Tanda Max Otc System.
| Device ID | K110735 |
| 510k Number | K110735 |
| Device Name: | TANDA MAX OTC SYSTEM |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | PHAROS LIFE CORPORATION 555 THIRTEENTH ST., NW Washington, DC 20004 |
| Contact | Johnathan S Kahan |
| Correspondent | Johnathan S Kahan PHAROS LIFE CORPORATION 555 THIRTEENTH ST., NW Washington, DC 20004 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-16 |
| Decision Date | 2011-08-03 |
| Summary: | summary |