Data / Medical devices / United States / Cutera, Inc.

Cutera, Inc.: FDA-registered device maker in Brisbane, CA, United States, 8 510(k) clearances

Name: Cutera, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cutera, Inc. is registered with the FDA (registration 2954354) in Brisbane, CA, United States. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 11, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2954354
FEI number: 3002900199
Address: 3240 Bayshore BLVD, Brisbane, CA, United States, 94005
Owner or operator: Cutera, Inc. (9038697)
Roles: Contract manufacturer, Manufacturer
First device listed: February 8, 2011
Registered through: 2026
Brand names listed: AcuTip 500, Limelight, ProWave 770, ProWave LX, AviClear, Pearl, Pearl Fractional, Titan XL, enlighten SR, enlighten III, enlighten Micro Lens Array, truFlex, truSculpt, truSculpt iD, truSculpt 40, truSculpt 16, xeo+, xeo+ SA, Acutip, Limelight, Prowave and more

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 11, 2025	K251149	AviClear Laser System	GEX	Substantially Equivalent	Cutera, Inc.	accessdata.fda.gov
December 15, 2023	K233237	xeo+ Family	GEX	Substantially Equivalent	Cutera, Inc.	accessdata.fda.gov
July 13, 2022	K221407	truSculpt iD	GEI	Substantially Equivalent	Cutera, Inc.	accessdata.fda.gov
December 12, 2018	K182997	enlighten III Laser System	GEX	Substantially Equivalent	Cutera, Inc.	accessdata.fda.gov
March 9, 2016	K153671	Family of CoolGlide Aesthetic Lasers	GEX	Substantially Equivalent	Cutera, Inc.	accessdata.fda.gov
August 15, 2008	K080530	MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE	GEX	Substantially Equivalent	Cutera, Inc.	accessdata.fda.gov
March 31, 2005	K050047	CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY	GEX	Substantially Equivalent	Cutera, Inc.	accessdata.fda.gov
February 17, 2004	K033768	ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE	ILY	Substantially Equivalent	Altus Medical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 16, 2013	66674	Class II	Terminated	Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide	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.	accessdata.fda.gov
May 8, 2010	55840	Not yet classified	Terminated	Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA Infrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical heating for the purpos	Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting.	accessdata.fda.gov

Compare with other makers

Updated July 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.