YZ3 Portable Slit Lamp

FDA 510(k) K131711 · Suzhou 66 Vision Tech Co., Ltd.

Substantially Equivalent

510(k) numberK131711

Submission

Device name
YZ3 Portable Slit Lamp
Applicant
Suzhou 66 Vision Tech Co., Ltd.
Suzhou, Jiangsu, CN
Received
June 11, 2013
Decision date
May 9, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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K222372Kowa SL-19HJO · Traditional Kowa Company , Ltd.11/21/2022SE
K193188MiiS Horus Eye Anterior CameraHJO · Traditional Medimaging Integrated Solution, Inc (Miis)01/14/2020SE
K182306Sunkingdom Slit LampHJO · Traditional Chongqing Sunkingdom Medical Instrument Co., Ltd.11/22/2018SE
K173771IOLMaster 700HJO · Traditional Carl Zeiss Meditec, AG08/24/2018SE
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

510(k)DeviceDecision
K05259966 Vision Tech Ophthalmoscope, Models YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25AHLJ · Traditional 11/07/2006SE
K033190Vision-Tech Yz Slit Lamp, Model 66HJO · Traditional 12/04/2003SE

Questions and answers

When was YZ3 Portable Slit Lamp cleared by the FDA?

YZ3 Portable Slit Lamp (K131711) received a 510(k) decision of Substantially Equivalent on May 9, 2014, 332 days after the submission was received.

What is the product code of K131711?

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