Aladdin

FDA 510(k) K131567 · Visia Imaging S.R.L.

Substantially Equivalent

510(k) numberK131567

Submission

Device name
Aladdin
Applicant
Visia Imaging S.R.L.
Ormond Beach, FL, US
Received
May 30, 2013
Decision date
June 5, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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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K171877SLM-1ER, SLM-2ER, SLM-3ERHJO · Traditional Chongqing Kanghua Ruiming S&T Co., Ltd.12/21/2017SE
K170470Digital Eye Anterior CameraHJO · Traditional Medimaging Integrated Solution, Inc (Miis)10/06/2017SE
K162778Portable Slit Lamp MicroscopeHJO · Traditional Suzhou Kangjie Medical, Inc.07/21/2017SE
K162684SL 220HJO · Traditional Carl Zeiss Meditec, AG05/31/2017SE

More from Carl Zeiss Meditec, AG

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Questions and answers

When was Aladdin cleared by the FDA?

Aladdin (K131567) received a 510(k) decision of Substantially Equivalent on June 5, 2014, 371 days after the submission was received.

What is the product code of K131567?

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