Cleared Traditional

COOPER LASER SONICS CUSA MODEL 200

K950945 · Valleylab, Inc. · General & Plastic Surgery
Apr 1995
Decision
82d
Days
Risk

About This 510(k) Submission

K950945 is an FDA 510(k) clearance for the COOPER LASER SONICS CUSA MODEL 200, a Instrument, Ultrasonic Surgical, submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on April 10, 1995, 82 days after receiving the submission on January 18, 1995. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K950945 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 1995
Decision Date April 10, 1995
Days to Decision 82 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

Similar Devices — LFL Instrument, Ultrasonic Surgical

All 156
CUSA? Clarity Ultrasonic Surgical Aspirator System
K251162 · Integra LifeSciences Corporation · Oct 2025
SanAgile? Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile? Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile? Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile? Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile? Ultrasonic Surgery Advanced Dissector (SASD45)
K242894 · Shanghai Saints Sages Surgical Co., Ltd. · Jun 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · Stryker Instruments · Mar 2025
Tenex 2nd Generation System
K241700 · Trice Medical, Inc. · Nov 2024
CUSA? Clarity Ultrasonic Surgical Aspirator System
K240493 · Integra LifeSciences Corporation · Jul 2024
Ultrasonic Surgical System
K233036 · Hunan Handlike Minimally Invasive Surgery Co., Ltd. · Jun 2024