NIDEK CYBERSCAN

K970017 · Nidek, Inc. · GEX · Mar 18, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970017
• Device Name: NIDEK CYBERSCAN
• Applicant: Nidek, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CyberScan Device is intended for use for all cleared Heraeus LaserSonics CO2 soft tissue surgical applications.(K955734)

Device Story

CyberScan Device is a scanning laser delivery system; functions as accessory to CO2 surgical lasers. Inputs: laser energy from CO2 laser source. Transforms inputs via scanning mechanism to deliver laser energy to soft tissue. Output: controlled laser beam for surgical cutting/ablation. Used in clinical/surgical settings by physicians. Output allows precise tissue interaction; benefits patient through controlled surgical outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and functional comparison to predicate.

Technological Characteristics

Scanning laser delivery system; designed for CO2 laser integration. Complies with 21 CFR 1040.10 and 1040.11 laser safety standards.

Indications for Use

Indicated for CO2 soft tissue surgical applications in patients requiring laser surgery.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• ParaScan Dosimeter Device (K955734)

Submission Summary (Full Text)

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MAR 18 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CYBERSCAN DEVICE SYSTEM K970017

### REGULAROY AUTHORITY:

Safe Medical Devices Act of 1990, 21 CFR 807.92

### COMPANY NAME/CONTACT:

Nidek Incorporated
47651 Westinghouse Drive
Fremont, CA. 94539-7474
Phone: [phone]
[phone]
Fax: [phone]

### DEVICE TRADE NAME

CyberScan Device

### DEVICE COMMON NAME

Scanning Laser Delivery System

### DEVICE CLASSIFICATION:

CO2 laser systems have been classified as Class II (79 GEX) medical devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels. To the best of our knowledge, scanning laser delivery systems have not been classified.

### PERFORMANCE STANDARDS:

The ParaScan Dosimeter Device complies with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.

### INDICATIONS FOR USE STATEMENT

The CyberScan Device is intended for use for all cleared Heraeus LaserSonics CO2 soft tissue surgical applications.(K955734)

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# COMPARISON WITH PREDICATE DEVICE:

The CyberScan Device is substantially equivalent to the ParaScan Dosimeter Device manufactured by Heraeus Surgical.(K955734)

The risks and benefits of the CyberScan are comparable to the predicate device when used for similar clinical applications.

Since the CyberScan Device is substantially equivalent with respect to indication for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510 (k) guidelines. Safety and effectiveness are reasonable assured, therefore justifying 510 (k) clearance.