Modified Alma Lasers Soprano XL Family Of Multi-Application & Multi-Technology Platform, Soprano YAG Hand Piece

Powered Laser Surgical Instrument

Alma Lasers Inc.

The following data is part of a premarket notification filed by Alma Lasers Inc. with the FDA for Modified Alma Lasers Soprano Xl Family Of Multi-application & Multi-technology Platform, Soprano Yag Hand Piece.

Pre-market Notification Details

Device IDK170626
510k NumberK170626
Device Name:Modified Alma Lasers Soprano XL Family Of Multi-Application & Multi-Technology Platform, Soprano YAG Hand Piece
ClassificationPowered Laser Surgical Instrument
Applicant Alma Lasers Inc. 485 Half Day Road Suite # 100 Buffalo Grove,  IL  60089
ContactRekha Anand
CorrespondentRekha Anand
Alma Lasers Inc. 485 Half Day Road Suite # 100 Buffalo Grove,  IL  60089
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-02
Decision Date2017-05-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290110121416 K170626 000

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