The following data is part of a premarket notification filed by Pharos Life Corporation with the FDA for Tanda Max.
| Device ID | K103415 |
| 510k Number | K103415 |
| Device Name: | TANDA MAX |
| Classification | Powered Light Based Non-laser Surgical Instrument |
| Applicant | PHAROS LIFE CORPORATION 11-380 JAMIESON PKWY Cambridge, Ontario, CA N3c 4n4 |
| Contact | Gordon Wehner |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ONE |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-11-22 |
| Decision Date | 2011-01-03 |
| Summary: | summary |