MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE

Powered Laser Surgical Instrument

CUTERA, INC.

The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Modification To Cutera Er:ysgg Laser Handpiece.

Pre-market Notification Details

Device IDK080530
510k NumberK080530
Device Name:MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
ClassificationPowered Laser Surgical Instrument
Applicant CUTERA, INC. 3240 BAYSHORE BLVD Brisbane,  CA  94005
ContactKathy Maynor
CorrespondentKathy Maynor
CUTERA, INC. 3240 BAYSHORE BLVD Brisbane,  CA  94005
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-26
Decision Date2008-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816722022844 K080530 000

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