Keeler/Konan Specular Microscope

FDA 510(k) K810403 · Keeler Optical Products , Ltd.

Substantially Equivalent

510(k) numberK810403

Submission

Device name
Keeler/Konan Specular Microscope
Applicant
Keeler Optical Products , Ltd.
Mchenry, IL, US
Received
February 18, 1981
Decision date
May 13, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HJO – Biomicroscope, Slit-Lamp, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1850
Specialty
Ophthalmic

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K170470Digital Eye Anterior CameraHJO · Traditional Medimaging Integrated Solution, Inc (Miis)10/06/2017SE
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K792255Nevyas Autopress Eye CompressorLCC · Traditional 12/11/1979SE
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K781892Locator, Foreign BodyHPM · Traditional 12/04/1978SE

Questions and answers

When was Keeler/Konan Specular Microscope cleared by the FDA?

Keeler/Konan Specular Microscope (K810403) received a 510(k) decision of Substantially Equivalent on May 13, 1981, 84 days after the submission was received.

What is the product code of K810403?

The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.