Cleared Special

K151101 - Lotus Series 4 Ultrasonic Surgical Syst...

K151101 · Sra Developments, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
84d
Days
-
Risk

K151101 is an FDA 510(k) clearance for the Lotus Series 4 Ultrasonic Surgical System & Accessories. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Sra Developments, Ltd. (Ashburton, Devon, GB). The FDA issued a Cleared decision on July 17, 2015 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sra Developments, Ltd. devices

FDA 510(k) Submission Details - K151101

510(k) Number K151101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2015
Decision Date July 17, 2015
Days to Decision 84 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 89
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