ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002


Device Classification Name

powered laser surgical instrument

510(k) Number K030338
Device Name ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002
Original Applicant
CURELIGHT LTD
555 thirteenth street, n.w.
washington, 
DC 
20004 -1109

Original Contact jonathan s kahan
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 01/31/2003
Decision Date 02/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No