BLUESHINE’S GOLD SERIES


Device Classification Name

lasers for temporary increase of clear nail in patients with onychomycosis

510(k) Number K110375
Device Name BLUESHINE’S GOLD SERIES
Applicant
BLUESHINE SRL
via g. querini 27
mestre, 

IT

30171

Applicant Contact chiara ricci
Correspondent
BLUESHINE SRL
via g. querini 27
mestre, 

IT

30171

Correspodent Contact chiara ricci
Regulation Number 878.4810
Classification Product Code
PDZ  
Subsequent Product Code
GEX  
Date Received 02/09/2011
Decision Date 02/23/2012
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