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 a medical device manufactured by El Global Trade, Ltd.. It received FDA 510(k) clearance on 2016-07-08 under approval 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. It is manufactured by El Global Trade, Ltd.. The 510(k) number is K161089.
When was sensiLight Mini approved by the FDA?
sensiLight Mini received FDA 510(k) clearance on 2016-07-08, under approval number K161089.
What company makes sensiLight Mini?
sensiLight Mini is manufactured by El Global Trade, Ltd..
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.