FEMTO LDV

Laser, Ophthalmic

SIE AG,SURGICAL INSTUMENT ENGINEERING

The following data is part of a premarket notification filed by Sie Ag,surgical Instument Engineering with the FDA for Femto Ldv.

Pre-market Notification Details

Device IDK112154
510k NumberK112154
Device Name:FEMTO LDV
ClassificationLaser, Ophthalmic
Applicant SIE AG,SURGICAL INSTUMENT ENGINEERING 5401 S. COTTONWOOD CT. Greenwood Village,  CO  80121
ContactKevin Walls
CorrespondentKevin Walls
SIE AG,SURGICAL INSTUMENT ENGINEERING 5401 S. COTTONWOOD CT. Greenwood Village,  CO  80121
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-27
Decision Date2012-03-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07640167750856 K112154 000
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07640167751044 K112154 000
07640167751037 K112154 000
07640167751020 K112154 000
07640167751013 K112154 000
07640167750023 K112154 000

Trademark Results [FEMTO LDV]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FEMTO LDV
FEMTO LDV
79288630 not registered Live/Pending
Ziemer Ophthalmic Systems AG
2020-04-02

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