Envisu Spectral Domain Ophthalmic Imaging System (Sdois)

FDA 510(k) K120057 · Bioptigen, Inc.

Substantially Equivalent

510(k) numberK120057

Submission

Device name
Envisu Spectral Domain Ophthalmic Imaging System (Sdois)
Applicant
Bioptigen, Inc.
Durham, NC, US
Received
January 9, 2012
Decision date
May 11, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HLI – Ophthalmoscope, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1570
Specialty
Ophthalmic

Other 510(k)s with product code HLI

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K153080RTVue XR OCT Avanti with AngioVue SoftwareHLI · Traditional Optovue, Inc.02/11/2016SE
K150722EnFocus 2300, EnFocus 4400HLI · Traditional Bioptigen, Inc.12/02/2015SE
K142953OCT-CameraHLI · Traditional Optomedical Technologies GmbH03/04/2015SE
K141638Propper Insight Binocular Indirect OphthalmosopeHLI · Abbreviated Propper Manufacturing Co., Inc.09/17/2014SE
K133758Centervue Macular Integrity AssessmentHLI · Traditional Centervue S.P.A.04/23/2014SE
K131939Amico DH-W35 Ophthalmoscope SeriesHLI · Traditional Amico Diagnostic Incorporated03/26/2014SE
K133892Ivue 500HLI · Traditional Optovue, Inc.03/19/2014SE
K123316Heine Omega 500HLI · Abbreviated Heine Optotechnik GmbH & Co. KG02/26/2013SE
K121739Ivue with Normative DatabaseHLI · Traditional Optovue, Inc.01/18/2013SE
K120238Rtvue XR OctHLI · Special Optovue, Inc.04/03/2012SE

More from Optovue, Inc.

510(k)DeviceDecision
K162783EnFocus 2300, EnFocus 4400OBO · Special 12/09/2016SE
K150722EnFocus 2300, EnFocus 4400HLI · Traditional 12/02/2015SE
K063343Bioptigen Spectral Domain Ophthalmic Imaging SystemHLI · Traditional 12/13/2006SE

Questions and answers

When was Envisu Spectral Domain Ophthalmic Imaging System (Sdois) cleared by the FDA?

Envisu Spectral Domain Ophthalmic Imaging System (Sdois) (K120057) received a 510(k) decision of Substantially Equivalent on May 11, 2012, 123 days after the submission was received.

What is the product code of K120057?

The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.