Cleared Traditional

BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM

K063343 · Bioptigen, Inc. · Ophthalmic

Dec 2006

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K063343 is an FDA 510(k) clearance for the BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Bioptigen, Inc. (Washington, US). The FDA issued a Cleared decision on December 13, 2006, 37 days after receiving the submission on November 6, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K063343 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 2006
Decision Date	December 13, 2006
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF