The Alma Opus System, Colibri Applicator And Tips

Electrosurgical, Cutting & Coagulation & Accessories

Alma Lasers Inc.

The following data is part of a premarket notification filed by Alma Lasers Inc. with the FDA for The Alma Opus System, Colibri Applicator And Tips.

Pre-market Notification Details

Device IDK201520
510k NumberK201520
Device Name:The Alma Opus System, Colibri Applicator And Tips
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Alma Lasers Inc. 485 Half Day Rd Ste 100 Buffalo Grove,  IL  60089
ContactJessica Rivera-montejo
CorrespondentKathy Maynor
Kathy Maynor Consulting 26 Rebecca Ct Homosassa,  FL  34446
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2021-10-27

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