JOULE CLEARSENSE LASER SYSTEM


Device Classification Name

lasers for temporary increase of clear nail in patients with onychomycosis

510(k) Number K111483
Device Name JOULE CLEARSENSE LASER SYSTEM
Applicant
SCITON, INC.
925 commercial st.
palo alto, 
CA 
94303

Applicant Contact jay m patel
Correspondent
SCITON, INC.
925 commercial st.
palo alto, 
CA 
94303

Correspodent Contact jay m patel
Regulation Number 878.4810
Classification Product Code
PDZ  
Subsequent Product Code
GEX  
Date Received 05/31/2011
Decision Date 12/07/2011
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