LAPEX 2000

Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy

MERIDIAN CO., LTD.

The following data is part of a premarket notification filed by Meridian Co., Ltd. with the FDA for Lapex 2000.

Pre-market Notification Details

Device IDK034009
510k NumberK034009
Device Name:LAPEX 2000
ClassificationPowered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Applicant MERIDIAN CO., LTD. PO BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
MERIDIAN CO., LTD. PO BOX 7007 Deerfield,  IL  60015
Product CodeNHN  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-24
Decision Date2005-01-21
Summary:summary

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