DERMATOLOGICAL TREATMENT DEVICE FAMILY


Device Classification Name

powered laser surgical instrument

510(k) Number K111303
Device Name DERMATOLOGICAL TREATMENT DEVICE FAMILY
Applicant
SHARPLIGHT TECHNOLOGIES LTD.
p.o. box 4262
zichron yaacov, 

IL

30900

Applicant Contact ilan sharon
Correspondent
SHARPLIGHT TECHNOLOGIES LTD.
p.o. box 4262
zichron yaacov, 

IL

30900

Correspodent Contact ilan sharon
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/09/2011
Decision Date 12/21/2011
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