Cleared Traditional

K071250 - CA, MODEL: CAM
(FDA 510(k) Clearance)

K071250 · Optovue, Inc. · Ophthalmic

Sep 2007

Decision

147d

Days

Class 2

Risk

K071250 is an FDA 510(k) clearance for the CA, MODEL: CAM, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on September 28, 2007, 147 days after receiving the submission on May 4, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K071250 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2007
Decision Date	September 28, 2007
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	OBO — Tomography, Optical Coherence
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.1570
Definition	Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.