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FDA 510(k)

Slit Lamp SL-D301

K-Number: K161972 · 2016-12-09

ApplicantTopcon Corporation
Decision Date2016-12-09
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Slit Lamp SL-D301 is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2016-12-09 under 510(k) number K161972. 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-D301?

Slit Lamp SL-D301 is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Topcon Corporation. The 510(k) number is K161972.

When did Slit Lamp SL-D301 receive FDA 510(k) clearance?

Slit Lamp SL-D301 received FDA 510(k) clearance on 2016-12-09, under 510(k) number K161972.

Who is the listed applicant for Slit Lamp SL-D301?

The FDA 510(k) record lists Topcon Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Slit Lamp SL-D301?

The FDA product code for Slit Lamp SL-D301 is HJO.

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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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