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FDA 510(k)

sensiLight Mini

K-Number: K161089 · 2016-07-08

ApplicantEl Global Trade, Ltd.
Decision Date2016-07-08
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

sensiLight Mini is the device name listed in this FDA 510(k) record. The listed applicant is El Global Trade, Ltd.. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K161089. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the sensiLight Mini?

sensiLight Mini is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is El Global Trade, Ltd.. The 510(k) number is K161089.

When did sensiLight Mini receive FDA 510(k) clearance?

sensiLight Mini received FDA 510(k) clearance on 2016-07-08, under 510(k) number K161089.

Who is the listed applicant for sensiLight Mini?

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

What is the FDA product code for sensiLight Mini?

The FDA product code for sensiLight Mini is OHT.

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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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