← Product Code [LFL](/productcode/LFL) · K960374

# ULTRACUT 2000 (K960374)

_Ultralase Technologies, Inc. · LFL · Jun 28, 1996 · SU · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K960374

## Device Facts

- **Applicant:** Ultralase Technologies, Inc.
- **Product Code:** [LFL](/productcode/LFL.md)
- **Decision Date:** Jun 28, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Indications for Use

The Ultracut 2000 is an ultrasonic surgical instrument intended for use to cut or fragment tissue, bone, or organs in orthopedic surgery.

## Device Story

Ultrasonic surgical instrument; utilizes piezoelectric transducer to generate 40kHz vibrations; variable amplitude (0-500μ) and power (0-100 watts); features integrated aspiration and irrigation; operated via footswitch; used in orthopedic surgery for tissue/bone/organ fragmentation; provides surgeon control over cutting parameters; benefits include precise tissue removal with concurrent aspiration/irrigation.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Piezoelectric transducer; 40kHz operating frequency; variable power (0-100W) and amplitude (0-500μ); titanium or stainless steel surgical tips; autoclave sterilization; console dimensions 4.5 x 12.25 x 11.125 inches; 115VAC power source.

## Predicate Devices

- Cavitron Ultrasonic Surgical Aspirator (CUSA) ([K801623](/device/K801623.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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K960374

# APPENDIX C

## SUMMARY OF SAFETY AND EFFECTIVENESS

JUN 28 1996

The Ultralase Ultracut 2000 is equivalent to the predicate device Cavitron Corporation’s Cavitron Ultrasonic Surgical Aspirator (CUSA). The Ultracut 2000 has the same general intended use, similar principles of operation, and similar technological characteristics as the predicate device. The Ultracut 2000 and CUSA are both ultrasonic surgical instruments intended for use to cut or fragment tissue, bone, or organs in orthopedic surgery.

## Comparison Chart

|   | Ultracut 2000 | CUSA (Model 200H)  |
| --- | --- | --- |
|  510(k) | Applied For | K801623  |
|  Console Dimensions (in) | 4.5 x 12.25 x 11.125 | 76 x 23 x 26  |
|  Power Specifications | 115VAC; 50/60 Hz | 115VAC; 50/60 Hz  |
|  Footswitch Control | Yes | Yes  |
|  Intended Use | Ultrasonic Surgery | Ultrasonic Surgery  |
|  Frequency | 40kHz | 37kHz  |
|  Vibration Amplitude | Variable, 0-500μ | Variable, 0-355μ  |
|  Power | Variable, 0-100 watts | Variable, 0-70 watts  |
|  Timer | Yes (1 sec - 100 min) | Yes (0 - 99 min)  |
|  Aspiration | Yes | Yes  |
|  Irrigation | Yes | Yes  |
|  Modes of Operation | Continuous | Continuous  |
|   | Pulsed On/Off | Pulsed On/Off  |
|  Handpiece Frequency | 40kHz | 37kHz  |
|  Dimensions (inches) | L 5.75 x D 1.25 | L 6.75  |
|  Removable Surgical Tips | Yes | Yes  |
|  Tip Material | Titanium or Stainless Steel | Titanium  |
|  Transducer | Piezoelectric | Magnetostrictive  |
|  Sterilization | Autoclave | EtO or Steam  |

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**Source:** [https://fda-staging.innolitics.com/device/K960374](https://fda-staging.innolitics.com/device/K960374)

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