Cleared Traditional

FORESEE HOME

K091579 · Notal Vision , Ltd. · Ophthalmic

Dec 2009

Decision

204d

Days

Class 1

Risk

About This 510(k) Submission

K091579 is an FDA 510(k) clearance for the FORESEE HOME, a Perimeter, Automatic, Ac-powered (Class I — General Controls, product code HPT), submitted by Notal Vision , Ltd. (Laguna Beach, US). The FDA issued a Cleared decision on December 23, 2009, 204 days after receiving the submission on June 2, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1605.

Submission Details

510(k) Number	K091579 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2009
Decision Date	December 23, 2009
Days to Decision	204 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF