FDA 510(k)

LIGHTSonic BUBM

K-Number: K170761 · 2018-04-13

Decision Date2018-04-13

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

LIGHTSonic BUBM is a medical device manufactured by Lightmed USA, Inc.. It received FDA 510(k) clearance on 2018-04-13 under approval number K170761. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHTSonic BUBM?

LIGHTSonic BUBM is a medical device that received FDA 510(k) clearance on 2018-04-13. It is manufactured by Lightmed USA, Inc.. The 510(k) number is K170761.

When was LIGHTSonic BUBM approved by the FDA?

LIGHTSonic BUBM received FDA 510(k) clearance on 2018-04-13, under approval number K170761.

What company makes LIGHTSonic BUBM?

LIGHTSonic BUBM is manufactured by Lightmed USA, Inc..

What is the FDA product code for LIGHTSonic BUBM?

The FDA product code for LIGHTSonic BUBM is IYO.

Other Devices by Lightmed USA, Inc.

K183173LIGHTMED Ultrasound System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.