Cleared Traditional

K170761 - LIGHTSonic BUBM

K170761 is the FDA 510(k) clearance for LIGHTSonic BUBM by Lightmed USA, Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 396-day FDA review.

K170761 · Lightmed USA, Inc. · Radiology device
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Apr 2018
Decision
396d
Days
Class 2
Risk

K170761 is an FDA 510(k) clearance for the LIGHTSonic BUBM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Lightmed USA, Inc. (San Clemente, US). The FDA issued a Cleared decision on April 13, 2018 after a review of 396 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lightmed USA, Inc. devices

Submission Details

510(k) Number K170761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2017
Decision Date April 13, 2018
Days to Decision 396 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
289d slower than avg
Panel avg: 107d · This submission: 396d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

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