Gemini 2 810+980 Soft Tissue Laser

Laser, Dental, Soft Tissue

Azena Medical, LLC

The following data is part of a premarket notification filed by Azena Medical, Llc with the FDA for Gemini 2 810+980 Soft Tissue Laser.

Pre-market Notification Details

Device IDK210350
510k NumberK210350
Device Name:Gemini 2 810+980 Soft Tissue Laser
ClassificationLaser, Dental, Soft Tissue
Applicant Azena Medical, LLC 3021 Citrus Circle Suite 180 Walnut Creek,  CA  94598
ContactLindsay Tilton
CorrespondentLindsay Tilton
Azena Medical, LLC 3021 Citrus Circle Suite 180 Walnut Creek,  CA  94598
Product CodeNVK  
Subsequent Product CodeGEX
Subsequent Product CodeILY
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-08
Decision Date2021-11-18

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