MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

ALMA LASERS INC.

The following data is part of a premarket notification filed by Alma Lasers Inc. with the FDA for Modified Alma Lasers Harmony 1064nm (nd:yag) Modules.

Pre-market Notification Details

Device IDK113810
510k NumberK113810
Device Name:MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
ClassificationLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Applicant ALMA LASERS INC. 485 HALF DAY RD. SUITW NO. 100 Buffalo Grove,  IL  60089
ContactTatiana Epstein
CorrespondentTatiana Epstein
ALMA LASERS INC. 485 HALF DAY RD. SUITW NO. 100 Buffalo Grove,  IL  60089
Product CodePDZ  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-23
Decision Date2012-03-08
Summary:summary

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