Daavlin NeoLux 3 Series User Manual

MNL-00008 [5] Proprietary and Confidential Page 6 of 55
2.0 Indications for Use
The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are
intended for use, by or under the direction of a physician, for therapeutic treatment for
individuals who require ultraviolet radiation for diagnosed skin disorders. When equipped with
blue lamps the ClearLink Controlled Phototherapy Equipment is intended for use for the
treatment of acne vulgaris.
Note: Only Daavlin’s 1 Series or 4 Series devices, when equipped with blue lamps and
controlled with the ClearLink Controlled Phototherapy Equipment, have intended use for the
treatment of acne vulgaris.
WARNING: Do not use these devices for anything other than their intended purposes.
CAUTION: Federal law restricts this device to sale by or on the order of a physician or any
other practitioner licensed by the law of the state in which he/she practices.
The 7 Series Phototherapy Device is not a Class III or implantable device. The Summary of Safety
and Clinical Performance is not required.
3.0 Classifications
FDA:
Class II Device
93/42/EEC:
Class IIa Device
IEC 60601-1:
Class I Device
Pollution Degree:
Class II
Mode of Operation:
Non-continuous
IEC/EN 62471:2006
UV Risk Group:
Risk Group 2 (Moderate-Risk)
WARNING: This device is designed for intermittent operation only and not for continuous use.
The device should not be cycled continuously for more than 10 minutes. After such time, the unit
should either be turned off or left idling for at least 10 minutes.

Daavlin NeoLux 3 Series Specifications

General

Brand	Daavlin
Model	NeoLux 3 Series
Category	Medical Equipment
Language	English