NeoLas

Powered Laser Surgical Instrument

SHEAUMANN LASER, INC

The following data is part of a premarket notification filed by Sheaumann Laser, Inc with the FDA for Neolas.

Pre-market Notification Details

Device IDK150664
510k NumberK150664
Device Name:NeoLas
ClassificationPowered Laser Surgical Instrument
Applicant SHEAUMANN LASER, INC 45 Bartlett Street Marlborough,  MA  01752
ContactKatina Sousa
CorrespondentKatina Sousa
SHEAUMANN LASER, INC 45 Bartlett Street Marlborough,  MA  01752
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-16
Decision Date2015-12-22
Summary:summary

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