The following data is part of a premarket notification filed by Pharos Life Corporation with the FDA for Tanda Skincare System, Plc-001, Tanda Blue, 414-001, Tanda Red, 660-001.
| Device ID | K070185 |
| 510k Number | K070185 |
| Device Name: | TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PHAROS LIFE CORPORATION 11-380 JAMIESON PKWY Cambridge, Ontario, CA N3c 4n4 |
| Contact | Phil Cuscuna |
| Correspondent | Phil Cuscuna PHAROS LIFE CORPORATION 11-380 JAMIESON PKWY Cambridge, Ontario, CA N3c 4n4 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-19 |
| Decision Date | 2007-08-21 |
| Summary: | summary |