Cleared Traditional

K120057 - ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
(FDA 510(k) Clearance)

K120057 · Bioptigen, Inc. · Ophthalmic

May 2012

Decision

123d

Days

Class 2

Risk

K120057 is an FDA 510(k) clearance for the ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS). This device is classified as a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI).

Submitted by Bioptigen, Inc. (Durham, US). The FDA issued a Cleared decision on May 11, 2012, 123 days after receiving the submission on January 9, 2012.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K120057 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 09, 2012
Decision Date	May 11, 2012
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF