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FDA 510(k)

HARMONY VLED SURGICAL LIGHTNING SYSTEM

K-Number: K100395 · 2010-03-17

ApplicantSTERIS Corporation
Decision Date2010-03-17
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HARMONY VLED SURGICAL LIGHTNING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2010-03-17 under 510(k) number K100395. The device is classified under product code FST. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARMONY VLED SURGICAL LIGHTNING SYSTEM?

HARMONY VLED SURGICAL LIGHTNING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-03-17. The listed applicant is STERIS Corporation. The 510(k) number is K100395.

When did HARMONY VLED SURGICAL LIGHTNING SYSTEM receive FDA 510(k) clearance?

HARMONY VLED SURGICAL LIGHTNING SYSTEM received FDA 510(k) clearance on 2010-03-17, under 510(k) number K100395.

Who is the listed applicant for HARMONY VLED SURGICAL LIGHTNING SYSTEM?

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

What is the FDA product code for HARMONY VLED SURGICAL LIGHTNING SYSTEM?

The FDA product code for HARMONY VLED SURGICAL LIGHTNING SYSTEM is FST.

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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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