Cutera Inc

FDA Filings

This page includes the latest FDA filings for Cutera Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USA

NASDAQ

CUTR

DUNS 041071643

FDA Registration(s)

• Registration Number: 2954354
• FEI Number: 3002900199
• Name: CUTERA, INC.
• Owner & Operator: Cutera, Inc.
• Contact Address: 3240 Bayshore Blvd. ; Brisbane CA 94005 US
• Official Correspondent:
  • Sam Mostafavi
  • 001-415-6575642-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3240 BAYSHORE BLVD ; BRISBANE, CA 94005 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 00816722022806 CUTERA, INC.	Acutip	2023-05-23
GUDID 00816722022844 CUTERA, INC.	Pearl Fractional	2022-12-08
GUDID 00816722022837 CUTERA, INC.	Titan	2022-12-08
GUDID 00816722022820 CUTERA, INC.	Prowave	2022-12-08
GUDID 00816722022813 CUTERA, INC.	Limelight	2022-12-08
GUDID 00816722021816 CUTERA, INC.	xeo+ SA	2022-12-08
GUDID 00816722021809 CUTERA, INC.	xeo+	2022-12-08
GUDID 00816722022486 CUTERA, INC.	truSculpt 5 RF handpiece	2022-11-22
GUDID 00816722022479 CUTERA, INC.	truSculpt 2 RF handpiece	2022-11-22
PMN K223110 Cutera Inc.	TruSculpt ID	2022-11-03
PMN K221407 Cutera Inc.	TruSculpt ID	2022-07-13
GUDID 00816722022707 CUTERA, INC.	AviClear	2022-04-11
GUDID 00816722021700 CUTERA, INC.	AviClear	2022-04-11
PMN K213461 Cutera, Inc.	AviClear Laser System	2022-03-24
PMN K192039 | NGX CUTERA, INC.	truSculpt flex	2020-03-31
GUDID 00816722022363 CUTERA, INC.	CoolView	2020-02-12
GUDID 00816722023209 CUTERA, INC.	Genesis Plus 1 mm Spot Size Adapter	2020-02-06
GUDID 00816722021502 CUTERA, INC.	excel HR	2020-02-06
GUDID 00816722021205 CUTERA, INC.	Genesis Plus	2020-02-06
GUDID 00816722021038 CUTERA, INC.	CoolGlide Genesis	2020-02-06
GUDID 00816722021021 CUTERA, INC.	CoolGlide Vantage	2020-02-06
GUDID 00816722021014 CUTERA, INC.	CoolGlide Excel	2020-02-06
GUDID 00816722021007 CUTERA, INC.	CoolGlide CV	2020-02-06
GUDID 00816722022325 CUTERA, INC.	CoolView	2020-02-05
GUDID 00816722022349 CUTERA, INC.	Dermastat	2020-02-04
GUDID 08167222022349 CUTERA, INC.	Dermastat	2019-07-23
GUDID 00816722022356 CUTERA, INC.	Genesis V	2019-07-23
GUDID 00816722021311 CUTERA, INC.	excel V+	2019-07-23
GUDID 00816722023605 CUTERA, INC.	enlighten	2019-02-14
GUDID 00816722022462 CUTERA, INC.	truSculpt iD Hands Free 40	2019-01-14
PMN K182997 | GEX CUTERA, INC.	enlighten Micro Lens Array	2018-12-20
PMN K182997 Cutera, Inc.	Enlighten III Laser System	2018-12-12
PMN K180709 | PBX CUTERA, INC.	truSculpt; truSculpt 3D; truSculpt iD	2018-10-05
PMN K180709 | GEI CUTERA, INC.	truSculpt; truSculpt 3D; truSculpt iD	2018-10-05
GUDID 00816722022455 CUTERA, INC.	truSculpt 40 Hand Held	2018-07-30
GUDID 00816722022448 CUTERA, INC.	truSculpt 16 Hand Held	2018-07-30
GUDID 00816722021427 CUTERA, INC.	truSculpt iD	2018-07-30
GUDID 00816722023100 CUTERA, INC.	Pearl Fractional Standoffs	2018-07-06
GUDID 00816722022318 CUTERA, INC.	Genesis V	2018-07-06
GUDID 00816722022301 CUTERA, INC.	CoolView	2018-07-06
GUDID 00816722022172 CUTERA, INC.	OPS600	2018-07-06
GUDID 00816722022165 CUTERA, INC.	LP560	2018-07-06
GUDID 00816722022158 CUTERA, INC.	Pearl Fractional	2018-07-06
GUDID 00816722022141 CUTERA, INC.	Pearl	2018-07-06
GUDID 00816722022134 CUTERA, INC.	ProWave LX	2018-07-06
GUDID 00816722022127 CUTERA, INC.	ProWave 770	2018-07-06
GUDID 00816722022110 CUTERA, INC.	LimeLight	2018-07-06
GUDID 00816722022103 CUTERA, INC.	AcuTip 500	2018-07-06
GUDID 00816722021915 CUTERA, INC.	Solera Titan	2018-07-06
GUDID 00816722021908 CUTERA, INC.	Solera Opus	2018-07-06
GUDID 00816722021649 CUTERA, INC.	enlighten	2018-07-06
GUDID 00816722021625 CUTERA, INC.	enlighten	2018-07-06
GUDID 00816722021304 CUTERA, INC.	excel V	2018-07-06
GUDID 00816722022431 CUTERA, INC.	truSculpt 3D	2018-06-26
GUDID 00816722021410 CUTERA, INC.	truSculpt	2018-06-26
PMN K180709 Cutera, Inc.	TruSculpt RF Device; TruSculpt; TruSculpt 3D	2018-06-06
GUDID 00816722022929 CUTERA, INC.	Titan S	2018-03-29
GUDID 00816722022912 CUTERA, INC.	Titan XL	2018-03-29
GUDID 00816722022905 CUTERA, INC.	Titan V	2018-03-29
GUDID 00816722022424 CUTERA, INC.	truSculpt 40	2018-03-29
GUDID 00816722022417 CUTERA, INC.	truSculpt 25	2018-03-29
GUDID 00816722022400 CUTERA, INC.	truSculpt 16	2018-03-29
GUDID 00816722021618 CUTERA, INC.	enlighten	2018-03-29
GUDID 00816722021601 CUTERA, INC.	enlighten	2018-03-29
GUDID 00816722021403 CUTERA, INC.	truSculpt	2018-03-29
GUDID 00816722021113 CUTERA, INC.	xeo SA	2018-03-29
GUDID 00816722021106 CUTERA, INC.	xeo	2018-03-29
PMN K172077 | GEX CUTERA, INC.	enlighten, enlighten SR, enlighten III	2017-11-09
PMN K172077 Cutera, Inc.	Cutera Enlighten III Laser System	2017-10-27
PMN K172004 Cutera, Inc.	TruSculpt	2017-08-02
PMN K170936 Cutera, Inc.	Cutera Enlighten III Laser System	2017-04-25
PMN K162512 CUTERA, INC.	TruSculpt	2016-12-09
PMN K160488 Cutera, Inc.	Cutera Enlighten III Laser System	2016-10-28
PMN K153671 CUTERA, INC.	Family Of CoolGlide Aesthetic Lasers	2016-03-09
PMN K140727 CUTERA, INC.	CUTERA PICOSECOND LASER SYSTEM	2014-11-06
PMN K133739 CUTERA, INC.	TRUSCULPT	2014-09-05
PMN K133945 CUTERA, INC.	CUTERA PICOSECOND LASER SYSTEM	2014-08-11
PMN K132185 | GEX CUTERA, INC.	excel HR, excel V, excel V+	2014-06-12
PMN K132185 CUTERA, INC.	FAMILY OF COOLGLIDE AESTHETIC LASERS	2013-12-06
PMN K003765 | GEX CUTERA, INC.	Lyra G	2013-09-19
PMN K122493 | PDZ CUTERA, INC.	GenesisPlus	2013-05-22
PMN K122493 | GEX CUTERA, INC.	GenesisPlus	2013-05-22
PMN K122493 CUTERA, INC.	GENESISPLUS	2013-05-15
PMN K122389 CUTERA, INC.	TRUSCULPT	2012-11-02
PMN K050679 | GEX CUTERA, INC.	Solera Opus	2012-10-31
PMN K990903 | GEX CUTERA, INC.	Lyra	2012-07-24
PMN K951034 | GEX CUTERA, INC.	Aura	2012-07-24
PMN K041930 | GEX CUTERA, INC.	VariLite	2012-02-03
PMN K034011 | GEX CUTERA, INC.	Gemini	2012-02-03
PMN K022226 | GEX CUTERA, INC.	Xeo	2011-08-18
PMN K102954 CUTERA, INC.	CUTERA QSWITCH LASER SYSTEM	2011-06-22
PMN K103626 CUTERA, INC.	CUTERA GENESISPLUS LASER SYSTEM	2011-04-05
PMN K063867 | GEX CUTERA, INC.	Pearl, Pearl Fractional	2011-02-08
PMN K050047 | GEX CUTERA, INC.	AcuTip 500, LimeLight, ProWave 770, ProWave LX, OPS600, LP560	2011-02-08
PMN K092195 CUTERA, INC.	CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)	2009-10-01
PMN K080530 CUTERA, INC.	MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE	2008-08-15
PMN K080300 CUTERA, INC.	CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)	2008-04-08
PMN K063867 CUTERA, INC.	CUTERA ER:YSGG LASER HANDPIECE	2007-03-27
PMN K042165 | ILY CUTERA, INC.	Solera Titan	2006-03-03
PMN K050679 CUTERA, INC.	CUTERA SOLERA OPUS AESTHETIC PRODUCT	2005-03-31
PMN K050047 CUTERA, INC.	CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY	2005-03-31
PMN K050069 CUTERA, INC.	CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT	2005-01-31
PMN K042165 CUTERA, INC.	CUTERA TABLETOP AESTHETIC PRODUCT	2004-10-18
PMN K023954 | GEX CUTERA, INC.	Xeo SA	1999-10-27
PMN K014040 | GEX CUTERA, INC.	CoolGlide CV, CoolGlide Excel, CoolGlide Vantage	1999-10-27

Related Finance Registrations

NCAGE Code	1WLX2	CUTERA, INC.!DBA CUTERA
CAGE Code	1WLX2	CUTERA, INC. CUTERA
DUNS	041071643	Cutera, Inc.
SEC	0001162461	CUTERA INC of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092639714	Yantian,China (Mainland) -> Oakland, California	PLASTIC PARTS 3PLTS=78CTNS .	78 CTN
2020072523894	Hong Kong,Hong Kong -> Oakland, California	PLASTIC PARTS 1PLT=4CTNS .	4 CTN
2020062528646	Hong Kong,Hong Kong -> Oakland, California	PLASTIC PARTS . .	55 CTN
2020052017052	Yantian,China (Mainland) -> Oakland, California	PLASTIC PARTS COVER, FRONT TOTAL:2PLTS=23 CARTONS	23 CTN
2020020347600	Wuhu,China (Mainland) -> Oakland, California	COVER, LEFT, BETA, TS2 TOTAL:5PLTS=65CARTONS .	65 CTN
2020010339478	Wuhu,China (Mainland) -> Oakland, California	COVER, FRONT HS CODE:8543909000 TOTAL:4PLTS=20 CARTONS	20 CTN
2019121127293	Wuhu,China (Mainland) -> Oakland, California	PLASTIC SHELL TOTAL:1 PLT=7 CARTONS .	7 CTN
2019102928809	Hong Kong,Hong Kong -> Oakland, California	PLASTIC CASE . .	16 CTN