PICASSO/ PICASSO LITE/ PICASSO PERIO

Powered Laser Surgical Instrument

AMD LASERS, LLC

The following data is part of a premarket notification filed by Amd Lasers, Llc with the FDA for Picasso/ Picasso Lite/ Picasso Perio.

Pre-market Notification Details

Device IDK102359
510k NumberK102359
Device Name:PICASSO/ PICASSO LITE/ PICASSO PERIO
ClassificationPowered Laser Surgical Instrument
Applicant AMD LASERS, LLC 7405 WESTFIELD BLVD. Indianapolis,  IN  46240
ContactAmy Szentes
CorrespondentAmy Szentes
AMD LASERS, LLC 7405 WESTFIELD BLVD. Indianapolis,  IN  46240
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-19
Decision Date2011-09-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D807115100011 K102359 000

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