FDA.reportPublic FDA data

CUTERA, INC.

Matched from indexed company URL: Cutera Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29543543002900199CUTERA, INC.1Y2026-01-013240 BAYSHORE BLVD BRISBANE CA US 94005

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00816722021014CoolGlide Excel - CoolGlide Excel Laser System1 415 657-5500info@cutera.com
00816722021021CoolGlide Vantage - CoolGlide Vantage Laser System1 415 657-5500info@cutera.com
00816722021038CoolGlide Genesis - CoolGlide Genesis Laser System1 415 657-5500info@cutera.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
565631111366887K990903LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)GEX1999-08-27
565631590873324K951034AURA LASER SYSTEMGEX1995-04-13
565631600188161K233237xeo+ FamilyGEX2023-12-15
565632043108745K213461AviClear Laser SystemGEX2022-03-24
565631526406380K192039Torc BodyNGX2020-03-29
565631889343827K182997enlighten III Laser SystemGEX2018-12-12
565631991834255K180709truSculpt RF Device; truSculpt; truSculpt 3DPBX2018-06-06
565631211228900K172077Cutera enlighten III Laser SystemGEX2017-10-27
565631107254551K132185FAMILY OF COOLGLIDE AESTHETIC LASERSGEX2013-12-06
565631953206231K122493GENESISPLUSGEX2013-05-15
565631291938378K080530MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECEGEX2008-08-15
565631129171675K063867CUTERA ER:YSGG LASER HANDPIECEGEX2007-03-27
565631797612655K050679CUTERA SOLERA OPUS AESTHETIC PRODUCTGEX2005-03-31
565631698738314K050047CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILYGEX2005-03-31
565631495520669K042165CUTERA TABLETOP AESTHETIC PRODUCTILY2004-10-18
565631104165935K041930VARILITE LASER SYSTEMGEX2004-09-10
565631197809908K034011GEMINI SURGICAL LASER SYSTEM & ACCESSORIESGEX2004-03-30
565631311356975K033768ALTUS MEDICAL OPTIONAL INFRARED HANDPIECEILY2004-02-17
565631253251571K023954ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIESGEX2003-03-18
565631091045745K022226ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELSGEX2002-10-08
565631357625256K014040FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELSGEX2002-06-03
565631788460507K003765LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)GEX2001-03-06
565631013946214

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX192023-12-15
ILY22004-10-18
NGX12020-03-29
PBX12018-06-06

PMN#

GUDID#

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