SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS


Device Classification Name

lens, contact, (disposable)

510(k) Number K080755
Device Name SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
Applicant
BAUSCH & LOMB, INC.
1400 north goodman st.
rochester, 
NY 
14609 -3547

Applicant Contact debra ketchum
Correspondent
BAUSCH & LOMB, INC.
1400 north goodman st.
rochester, 
NY 
14609 -3547

Correspodent Contact debra ketchum
Regulation Number 886.5925
Classification Product Code
MVN  
Date Received 03/17/2008
Decision Date 06/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No