GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K110835
Device Name GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
Applicant
GEO MEDICAL CO., LTD.
27001 la paz road
suite 312
mission viejo, 
CA 
92691

Applicant Contact albert rego
Correspondent
GEO MEDICAL CO., LTD.
27001 la paz road
suite 312
mission viejo, 
CA 
92691

Correspodent Contact albert rego
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 03/25/2011
Decision Date 04/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No