OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER

Powered Laser Surgical Instrument

OBERON GMBH FIBER TECHNOLOGIES

The following data is part of a premarket notification filed by Oberon Gmbh Fiber Technologies with the FDA for Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission Fiber, Dental Surgery Fiber.

Pre-market Notification Details

Device IDK140470
510k NumberK140470
Device Name:OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER
ClassificationPowered Laser Surgical Instrument
Applicant OBERON GMBH FIBER TECHNOLOGIES 7404 W. DETROIT STREET, STE 140 Chandler,  AZ  85226
ContactArmin Kaus
CorrespondentArmin Kaus
OBERON GMBH FIBER TECHNOLOGIES 7404 W. DETROIT STREET, STE 140 Chandler,  AZ  85226
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-25
Decision Date2014-10-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EOBN270120S0 K140470 000
EOBN200029S0 K140470 000
EOBN220126S0 K140470 000
EOBN210167S0 K140470 000
EOBN270123S0 K140470 000
EOBN270122S0 K140470 000
EOBN210138S0 K140470 000
EOBN210137S0 K140470 000
EOBN210136S0 K140470 000
EOBN210135S0 K140470 000
EOBN220138S0 K140470 000
EOBN270518S0 K140470 000
EOBN270192S0 K140470 000
EOBN270191S0 K140470 000
EOBN270190S0 K140470 000
EOBN210181S0 K140470 000
EOBN210180S0 K140470 000
EOBN210110S0 K140470 000
EOBN210111S0 K140470 000
EOBN210112S0 K140470 000
EOBN270119S0 K140470 000
EOBN270118S0 K140470 000
EOBN270117S0 K140470 000
EOBN270082S0 K140470 000
EOBN270055S0 K140470 000
EOBN270029S0 K140470 000
EOBN230053S0 K140470 000
EOBN230052N0 K140470 000
EOBN230051N0 K140470 000
EOBN230031S0 K140470 000
EOBN220051S0 K140470 000
EOBN210117S0 K140470 000
EOBN210116S0 K140470 000
EOBN210115S0 K140470 000
EOBN210114S0 K140470 000
EOBN210113S0 K140470 000
EOBN220105S0 K140470 000

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