Gemini 810+980 Soft Tissue Laser

Powered Laser Surgical Instrument

Azena Medical, LLC

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

Pre-market Notification Details

Device IDK192617
510k NumberK192617
Device Name:Gemini 810+980 Soft Tissue Laser
ClassificationPowered Laser Surgical Instrument
Applicant Azena Medical, LLC 3021 Citrus Circle Ste 180 Walnut Creek,  CA  94598
ContactLindsay Tilton
CorrespondentLindsay Tilton
Azena Medical, LLC 3021 Citrus Circle Ste 180 Walnut Creek,  CA  94598
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-23
Decision Date2020-02-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00861407000389 K192617 000

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