Cleared Traditional

FAMILY OF DISPOSABLE LENSES

K140368 · Sensor Medical Technology, LLC · Ophthalmic

Apr 2014

Decision

74d

Days

Class 1

Risk

About This 510(k) Submission

K140368 is an FDA 510(k) clearance for the FAMILY OF DISPOSABLE LENSES, a Prism, Gonioscopic (Class I — General Controls, product code HKS), submitted by Sensor Medical Technology, LLC (North Reading, US). The FDA issued a Cleared decision on April 29, 2014, 74 days after receiving the submission on February 14, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1660.

Submission Details

510(k) Number	K140368 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2014
Decision Date	April 29, 2014
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF