FDA 510(k)

SLIT LAMP SL-2000

K-Number: K163564 · 2017-05-19

Decision Date2017-05-19

Product CodeHJO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SLIT LAMP SL-2000 is a medical device manufactured by Nidek Co., Ltd.. It received FDA 510(k) clearance on 2017-05-19 under approval number K163564. 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 SLIT LAMP SL-2000?

SLIT LAMP SL-2000 is a medical device that received FDA 510(k) clearance on 2017-05-19. It is manufactured by Nidek Co., Ltd.. The 510(k) number is K163564.

When was SLIT LAMP SL-2000 approved by the FDA?

SLIT LAMP SL-2000 received FDA 510(k) clearance on 2017-05-19, under approval number K163564.

What company makes SLIT LAMP SL-2000?

SLIT LAMP SL-2000 is manufactured by Nidek Co., Ltd..

What is the FDA product code for SLIT LAMP SL-2000?

The FDA product code for SLIT LAMP SL-2000 is HJO.

Other Devices by Nidek Co., Ltd.

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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.