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 the device name listed in this FDA 510(k) record. The listed applicant is Lightmed USA, Inc.. It received FDA 510(k) clearance on 2018-04-13 under 510(k) 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. The listed applicant is Lightmed USA, Inc.. The 510(k) number is K170761.

When did LIGHTSonic BUBM receive FDA 510(k) clearance?

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

Who is the listed applicant for LIGHTSonic BUBM?

The FDA 510(k) record lists Lightmed USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIGHTSonic BUBM?

The FDA product code for LIGHTSonic BUBM is IYO.

Other records listing Lightmed USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.