VISULUX
K-Number: K161607 · 2017-02-23
ApplicantCarl Zeiss Meditec, AG
Decision Date2017-02-23
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
VISULUX is a medical device manufactured by Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2017-02-23 under approval number K161607. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VISULUX?
VISULUX is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by Carl Zeiss Meditec, AG. The 510(k) number is K161607.
When was VISULUX approved by the FDA?
VISULUX received FDA 510(k) clearance on 2017-02-23, under approval number K161607.
What company makes VISULUX?
VISULUX is manufactured by Carl Zeiss Meditec, AG.
What is the FDA product code for VISULUX?
The FDA product code for VISULUX is HJO.
Other Devices by Carl Zeiss Meditec, AG
Related Devices (Code: HJO)
K161972Slit Lamp SL-D301Topcon Corporation
K160327ALADDIN HW3.0Visia Imaging S.R.L.
K153545Portable Slit LampShanghai Bolan Optical-Electric Co., Ltd.
K152535Z5 Slit lamp microscope, Z2 Slit lamp microscopeTakagi Seiko Co., Ltd.
K152429Slit Lamp MicroscopeShanghai Mediworks Precision Instruments Co. , Ltd.
K171877SLM-1ER, SLM-2ER, SLM-3ERChongqing Kanghua Ruiming S&T Co., Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.