Cleared Traditional

AUTOLENS CLEANING AND DISINFECTING UNIT

K021699 · Autolens, Inc. · Ophthalmic

Dec 2002

Decision

208d

Days

Class 2

Risk

About This 510(k) Submission

K021699 is an FDA 510(k) clearance for the AUTOLENS CLEANING AND DISINFECTING UNIT, a Accessories, Solution, Ultrasonic Cleaners For Lenses (Class II — Special Controls, product code LYL), submitted by Autolens, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on December 16, 2002, 208 days after receiving the submission on May 22, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number	K021699 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2002
Decision Date	December 16, 2002
Days to Decision	208 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF