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Quality and Regulatory
6.
6.1.
Quality Systems
The FXi was designed, developed, and manufactured in accordance with ISO13485:2016 – Medical Devices – Quality management systems.
6.2.
Device Classification
The FXi complies with 21 CFR Chapter 1, Sub chapter J, as administered by the Center for Devices and Radiological Health (CDRH) of the US
Food and Drug Administration (FDA).
According to the applicable standards, the laser system is classified as follows:
•
Class I Type B device per EN/IEC 60601-1
Class 4 laser product according to IEC 60825-1
•
6.3.
Declaration of Conformity (EU)
PRODUCT IDENTIFICATION
Product name
LightForce
®
Therapy Lasers
MANUFACTURER
Name of company
LiteCure, LLC
AUTHORIZED REPRESENTATIVE
Name of company
Emergo Europe
REGISTRATION INFORMATION
Notified Body and ID #
BSI Group, 2797
CONFORMITY ASSESSMENT
Device classification
Class IIa
Rule 9
LiteCure, LLC declares that the above-mentioned product meets the fundamental requirements of the applied standards and the Medical Device
Directive 93/42/EEC+2007/47/EEC as transposed in the national laws of the Member States.
Specifications and Environmental Conditions
7.
7.1.
System Specifications (LightForce FXi)
Device Family Name
Model Number
Device Classifications
USFDA Medical Device
Medical Electrical Equipment
Laser Product
User Interface
Touch Screen Display
Emission Indicator
Mechanical Specifications
Dimensions
Weight
Environmental Specifications
Operation temperature
Charging temperature
Storage temperature
Humidity
Pressure
Cooling
RSR-000886-000 (5)
Model/number
LTC-1510-L-B6
Address
101 Lukens Drive, Suite A
New Castle, DE 19720
USA
Address
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Marking
Route to compliance
Annex II of MDD 93/42/EEC
Council Directive
LTC-1510-L-B6
Class II Medical Device per USFDA 21CFR 890.5500
Class I Type B device per EN/IEC 60601-1
Class 4 laser product per IEC 60825-1
10" HD Display with Touch Screen
Audible Signal (50 to 75 dB), LED (front display)
38 cm (L) x 28 cm (W) x 20 cm (H)
4 kg
10°C to 35°C
10°C to 32°C
-20°C to 70°C
≤ 80% RH Non-Condensing
70-106 kPa
Thermal Electrically Cooled with Forced Air
LightForce
®
FXi
Representative
Quality & Regulatory Director
Telephone/email
+31.70.345.8570 - phone
+31.70.346.7299 - fax
europe@emergogroup.com
CE certificate number
CE 542523
Standards applied
IEC 60601-1:2005+A1:2012
IEC 60601-1-2:2015
IEC 60601-1-6:2010+A1:2013
IEC 60601-2-22:2007+A1:2013
IEC 60825-1:2014
LightForce Therapy Lasers - LTC
LightForce
®
FXi
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