SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K121201
Device Name SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS
Applicant
ST. SHINE OPTICAL CO., LTD.
4,5 f/l no. 276-2 sec. 1
tatung rd.,hsi chin dist
new taipei city, 

TW

221

Applicant Contact ella lee
Correspondent
ST. SHINE OPTICAL CO., LTD.
4,5 f/l no. 276-2 sec. 1
tatung rd.,hsi chin dist
new taipei city, 

TW

221

Correspodent Contact ella lee
Regulation Number 886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received 04/19/2012
Decision Date 10/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No