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 |