MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS

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 Family Of Soprano Xl Multi-application Platmforms.

Pre-market Notification Details

Device IDK102716
510k NumberK102716
Device Name:MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS
ClassificationPowered Laser Surgical Instrument
Applicant ALMA LASERS, INC. 485 HALF DAY RD. SUITE #100 Buffalo Grove,  IL  60089
ContactTatiana Epstein
CorrespondentTatiana Epstein
ALMA LASERS, INC. 485 HALF DAY RD. SUITE #100 Buffalo Grove,  IL  60089
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-21
Decision Date2010-09-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290110120990 K102716 000

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