TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001

Powered Laser Surgical Instrument

PHAROS LIFE CORPORATION

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.

Pre-market Notification Details

Device IDK070185
510k NumberK070185
Device Name:TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001
ClassificationPowered Laser Surgical Instrument
Applicant PHAROS LIFE CORPORATION 11-380 JAMIESON PKWY Cambridge, Ontario,  CA N3c 4n4
ContactPhil Cuscuna
CorrespondentPhil Cuscuna
PHAROS LIFE CORPORATION 11-380 JAMIESON PKWY Cambridge, Ontario,  CA N3c 4n4
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-19
Decision Date2007-08-21
Summary:summary

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