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FDA 510(k)

LC-250 INFRARED LIGHT COAGULATOR

K-Number: K964380 · 1997-01-22

ApplicantNk-Optik America
Decision Date1997-01-22
Product CodeHQB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LC-250 INFRARED LIGHT COAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Nk-Optik America. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K964380. The device is classified under product code HQB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LC-250 INFRARED LIGHT COAGULATOR?

LC-250 INFRARED LIGHT COAGULATOR is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Nk-Optik America. The 510(k) number is K964380.

When did LC-250 INFRARED LIGHT COAGULATOR receive FDA 510(k) clearance?

LC-250 INFRARED LIGHT COAGULATOR received FDA 510(k) clearance on 1997-01-22, under 510(k) number K964380.

Who is the listed applicant for LC-250 INFRARED LIGHT COAGULATOR?

The FDA 510(k) record lists Nk-Optik America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LC-250 INFRARED LIGHT COAGULATOR?

The FDA product code for LC-250 INFRARED LIGHT COAGULATOR is HQB.

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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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