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CUTERA, INC.

United States·US-MF-000010456

Last updated September 17, 2026

Information

Country: United States
Address: 3240, Bayshore Blvd, Brisbane, United States
Website: www.cutera.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 415-657-5500
PRRC Contact: Philipp Novales-Li
EUDAMED SRN: US-MF-000010456
FDA FEI Number: 3002900199
DUNS Number: 041071643

Catalogue (85)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Cutera Picosecond Laser System	K140727	FDA 510(k)	Class II	Active
Cutera Solera Opus Aesthetic Product	K050679	FDA 510(k)	Class II	Active
Cutera Genesisplus Laser System	K103626	FDA 510(k)	Class II	Active
Family Of Coolglide Aesthetic Lasers	K132185	FDA 510(k)	Class II	Active
Cutera Flashlamp Tabletop Aesthetic Product	K050069	FDA 510(k)	Class II	Active
truSculpt iD	K223110	FDA 510(k)	Class II	Active
Genesisplus	K122493	FDA 510(k)	Class II	Active
Cutera Multimodal Cellulite Product (cmmcd)	K092195	FDA 510(k)	Class II	Active
truSculpt iD	K221407	FDA 510(k)	Class II	Active
Cutera Er:yag Laser Handpiece	K070138	FDA 510(k)	Class II	Active
xeo+ Family	K233237	FDA 510(k)	Class II	Active
Cutera Qswitch Laser System	K102954	FDA 510(k)	Class II	Active
AviClear Laser System	K251149	FDA 510(k)	Class II	Active
Cutera Multimodal Cellulite Product (cmmcd)	K080300	FDA 510(k)	Class II	Active
Prowave	7003137	EUDAMEDFDA UDI	Class IIb	Active
enlighten SR	ENLIGHTENSR	EUDAMEDFDA UDI	Class IIb	Active
Titan XL	7000301	EUDAMEDFDA UDI	Class IIb	Active
Limelight	7003138	EUDAMEDFDA UDI	Class IIb	Active
Limelight	7000335	EUDAMEDFDA UDI	Class IIb	Active
ProWave LX	7001049	EUDAMEDFDA UDI	Class IIb	Active
xeo SA	XEOSA	EUDAMEDFDA UDI	Class IIb	Active
truSculpt 40 HH	7001921	EUDAMEDFDA UDI	Class IIb	Active
excel V+	EXCELV+	EUDAMEDFDA UDI	Class IIb	Active
Genesis V	7002210, 7002085T	EUDAMEDFDA UDI	Class IIb	Active
xeo+	XEO+	EUDAMEDFDA UDI	Class IIb	Active
enlighten III	ENLIGHTENIII	EUDAMEDFDA 510(k)FDA UDI	Class IIb	Active
Dermastat 2 mm	7002212, 7002212T	EUDAMEDFDA UDI	Class IIb	Active
Acutip	7003139	EUDAMEDFDA UDI	Class IIb	Active
xeo+ SA	XEO+SA	EUDAMEDFDA UDI	Class IIb	Active
Dermastat 1 mm	7002211, 7002211T	EUDAMED	Class IIb	Active
AcuTip 500	7000278	EUDAMEDFDA UDI	Class IIb	Active
truSculpt 40 HF	7001920	EUDAMEDFDA UDI	Class IIb	Active
AviClear	AVICLEAR	EUDAMEDFDA UDI	Class IIb	Active
Pearl Fractional	7000515	EUDAMEDFDA UDI	Class IIb	Active
excel HR	EXCELHR	EUDAMEDFDA UDI	Class IIb	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 16, 2013	Z-0427-2014	—	terminated	Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin.
May 8, 2010	Z-0329-2011	—	terminated	Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting.