SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K110452
Device Name SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
Applicant
UNILENS CORP., USA
10431 72nd st. north
largo, 
FL 
33777

Applicant Contact alan j frazer
Correspondent
UNILENS CORP., USA
10431 72nd st. north
largo, 
FL 
33777

Correspodent Contact alan j frazer
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 02/16/2011
Decision Date 04/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No