TANDA SKINCARE SYSTEM, MODEL: PTSCS


Device Classification Name

powered laser surgical instrument

510(k) Number K080591
Device Name TANDA SKINCARE SYSTEM, MODEL: PTSCS
Applicant
PHAROS LIFE CORPORATION
11-380 jamieson pkwy
cambridge, 

CA

n3c 4n4

Applicant Contact phil cuscuna
Correspondent
PHAROS LIFE CORPORATION
11-380 jamieson pkwy
cambridge, 

CA

n3c 4n4

Correspodent Contact phil cuscuna
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 03/03/2008
Decision Date 11/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No