SMARTLENS


the company

Device Classification Name

tonometer, ac-powered

510(k) Number K002510
Device Name SMARTLENS
Original Applicant
ODC OPHTHALMIC DEVELOPMENT CO. AG
777 s. wadsworth blvd.
bldg. 2, suite 102
lakewood, 
CO 
80226

Original Contact kevin walls
Regulation Number 886.1930
Classification Product Code
HKX  
Date Received 08/15/2000
Decision Date 10/18/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No