Cleared Traditional

K103266 - ISTAND
(FDA 510(k) Clearance)

K103266 · Optovue, Inc. · Ophthalmic

Jun 2011

Decision

211d

Days

Class 2

Risk

K103266 is an FDA 510(k) clearance for the ISTAND, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on June 3, 2011, 211 days after receiving the submission on November 4, 2010. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K103266 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 2010
Decision Date	June 03, 2011
Days to Decision	211 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF