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Humidity limitation
Class 1 laser
product
Batch code
Catalog number
Date of manufacture
Non-ionizing
radiation
13. Laser Certification
The Earlens Light-Driven Hearing Aid complies with 21CFR 1040.10 and 1040.11.
Manufacturer (Ref. ISO 15223-1:2012, 5.1.1):
Earlens Corporation, Inc.
4045A Campbell Ave.
Menlo Park, CA 94025
European Authorized Representative (Ref. ISO 15223-1:2012, 5.1.2):
Medimark® Europe SARL
11, Rue Emile Zola, B.P. 2332
F-38033 Grenoble Cedex 2 – France
0459
©2017 Earlens, Inc. All rights reserved.
Patent Protected/Pending: www.earlens.com/patents
TM
Earlens Photon
and the Earlens Control app are compatible with the following Apple devices:
iPhone 7 Plus, iPhone 7, iPhone SE, iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone
5s, iPhone 5c, iPhone 5, iPad Pro, iPad Air 2, iPad Air, iPad (4th generation), iPad mini 4, iPad
mini 3, iPad mini with Retina display, iPad mini, iPod touch (5th generation) using iOS 9 or later.
ISO 15223-
1:2012, 5.3.8
IEC 60825-
1:2007, 5.2
ISO 15223-
1:2012, 5.1.5
ISO 15223-
1:2012, 5.1.6
0459
ISO 15223-
1:2012, 5.1.3
IEC 60601-1-
2:2007
IEC 60417-
5140 (2003-
04)
ISO 15223-
Caution
1:2012, 5.4.4
ASTM F2503-
MR unsafe
FCC Guidelines
FCC Part 18
Declaration of
Labeling, Part
Conformity
15 and Part 18,
2014
MDD
CE conformity
93/42/EEC,
marking
Annex XII
IEC 60601-
Type BF applied
1:2005
part
IEC 60417-
5333
IFU00021vH
13
for
11
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