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FDA 510(k)

SLIT LAMP SL-2000

K-Number: K163564 · 2017-05-19

ApplicantNidek Co., Ltd.
Decision Date2017-05-19
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SLIT LAMP SL-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Co., Ltd.. It received FDA 510(k) clearance on 2017-05-19 under 510(k) 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. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K163564.

When did SLIT LAMP SL-2000 receive FDA 510(k) clearance?

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

Who is the listed applicant for SLIT LAMP SL-2000?

The FDA 510(k) record lists Nidek Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Nidek Co., Ltd. as applicant

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Related Devices (Code: HJO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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