SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR


Device Classification Name

lens, contact (other material) – daily

510(k) Number K080193
Device Name SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR
Applicant
Synergeyes, Inc.
15825 shady grove road
suite 30
rockville, 
MD 
20850

Applicant Contact richard e lippman
Correspondent
Synergeyes, Inc.
15825 shady grove road
suite 30
rockville, 
MD 
20850

Correspodent Contact richard e lippman
Regulation Number 886.5916
Classification Product Code
HQD  
Date Received 01/25/2008
Decision Date 03/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No