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
Indications for 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.
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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: (510)226-5700
(800) 223-9044
Fax: (510) 2265750
### 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.
