Cleared Traditional

K101561 - TX1 TISSUE REMOVAL SYSTEM

K101561 · American Optisurgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
84d
Days
-
Risk

K101561 is an FDA 510(k) clearance for the TX1 TISSUE REMOVAL SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by American Optisurgical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on August 27, 2010 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K101561

510(k) Number K101561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2010
Decision Date August 27, 2010
Days to Decision 84 days
Submission Type Traditional
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
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 154
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K101561 · TX1 TISSUE REMOVAL SYSTEM
Download PDF FDA Summary American Optisurgical…