RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012

Device Classification Name

powered laser surgical instrument

510(k) Number K033183
Device Name RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012
Applicant
CURELIGHT LTD
555 thirteenth street, n.w.
washington, 
DC 
20004 -1109

Applicant Contact jonathan s kahan
Correspondent
CURELIGHT LTD
555 thirteenth street, n.w.
washington, 
DC 
20004 -1109

Correspodent Contact jonathan s kahan
Regulation Number 878.4810
Classification Product Code
GEX  
Subsequent Product Code
ILY  
Date Received 10/01/2003
Decision Date 04/15/2004
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