COOLTOUCH


Device Classification Name

lasers for temporary increase of clear nail in patients with onychomycosis

510(k) Number K103338
Device Name COOLTOUCH
Applicant
NEW STAR LASERS, INC.
9085 foothills blvd.
roseville, 
CA 
95747

Applicant Contact natalie r vollrath
Correspondent
NEW STAR LASERS, INC.
9085 foothills blvd.
roseville, 
CA 
95747

Correspodent Contact natalie r vollrath
Regulation Number 878.4810
Classification Product Code
PDZ  
Subsequent Product Code
GEX  
Date Received 11/15/2010
Decision Date 11/01/2011
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