AUTOLENS CLEANING AND DISINFECTING UNIT


Device Classification Name

accessories, solution, ultrasonic cleaners for lenses

510(k) Number K021699
Device Name AUTOLENS CLEANING AND DISINFECTING UNIT
Original Applicant
AUTOLENS INC.
17003 horn point dr.
gaithersburg, 
MD 
20878

Original Contact richard e lippman
Regulation Number 886.5928
Classification Product Code
LYL  
Subsequent Product Code
LPN  
Date Received 05/22/2002
Decision Date 12/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No