CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY

Powered Laser Surgical Instrument

CUTERA, INC.

The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Cutera Optional Pulsed Light Hand Piece Family.

Pre-market Notification Details

Device IDK050047
510k NumberK050047
Device Name:CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-10
Decision Date2005-03-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816722022172 K050047 000
00816722022165 K050047 000
00816722022134 K050047 000
00816722022127 K050047 000
00816722022110 K050047 000
00816722022103 K050047 000
00816722022820 K050047 000
00816722022813 K050047 000
00816722022806 K050047 000

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