SMARTEPIL,DEPILASE YAG LASE PLUS


Device Classification Name

powered laser surgical instrument

510(k) Number K112141
Device Name SMARTEPIL,DEPILASE YAG LASE PLUS
Applicant
CASTLE LASER SYSTEMS, LIMITED
641 sshunpike rd
suite 311
chatham, 
NJ 
07928

Applicant Contact raymond r blanche
Correspondent
CASTLE LASER SYSTEMS, LIMITED
641 sshunpike rd
suite 311
chatham, 
NJ 
07928

Correspodent Contact raymond r blanche
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/26/2011
Decision Date 04/13/2012
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