Cleared Traditional

Sensor Medical Family of Vitrectomy Lenses and Products

K142715 · Sensor Medical Technology, LLC · Ophthalmic

Dec 2014

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K142715 is an FDA 510(k) clearance for the Sensor Medical Family of Vitrectomy Lenses and Products, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Sensor Medical Technology, LLC (Maple Valley, US). The FDA issued a Cleared decision on December 16, 2014, 85 days after receiving the submission on September 22, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number	K142715 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2014
Decision Date	December 16, 2014
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF