Data / Medical devices / United States / Cartessa Aesthetics

Cartessa Aesthetics: FDA-registered device maker in Melville, NY, United States, 13 510(k) clearances

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

Cartessa Aesthetics is registered with the FDA (registration 3013602304) in Melville, NY, United States. It lists 10 device types. The FDA files 13 510(k) clearances under its listings, the newest dated November 21, 2024. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Cartessa Aesthetics

FDA registration number: 3013602304
Address: 175 Broadhollow Rd Ste 220, Melville, NY, United States, 11747
Owner or operator: Cartessa Aesthetics (10055766)
Roles: Complaint file establishment
First device listed: April 30, 2019
Registered through: 2027
Brand names listed: Aliya, Everesse, Helix, Lipo AI, Motus Pro, Physiq 360, Prisma, Quadessy and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Complaint file establishment	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment	accessdata.fda.gov
Laser For Disruption Of Adipocyte Cells For Aesthetic Use	PKT	2	Complaint file establishment	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Complaint file establishment	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Complaint file establishment	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Complaint file establishment	accessdata.fda.gov
Skin Resurfacing Rf Applicator	OUH	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Complaint file establishment	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
November 21, 2024	K241157	Secret MAX Multi-platform RF System	GEI	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
June 21, 2024	K241459	MOTUS PRO Family	GEX	Substantially Equivalent	El.En S.P.A.	accessdata.fda.gov
May 16, 2024	K240752	DEKA TORO	GEX	Substantially Equivalent	El.En S.P.A.	accessdata.fda.gov
May 16, 2024	K233473	DEKA LOTUS	ONF	Substantially Equivalent	El.En S.P.A.	accessdata.fda.gov
April 29, 2024	K240248	Volnewmer	GEI	Substantially Equivalent	Classys, Inc.	accessdata.fda.gov
March 12, 2024	K240497	Smartxide Tetra Pro	GEX	Substantially Equivalent	El.En S.P.A.	accessdata.fda.gov
December 19, 2023	K233470	DEKA LILY	NGX	Substantially Equivalent	El.En S.P.A.	accessdata.fda.gov
September 26, 2023	K231971	DEKA PHYSIQ 360	PKT	Substantially Equivalent	El.En S.P.A.	accessdata.fda.gov
September 1, 2023	K232334	DEKA SIMON	IPF	Substantially Equivalent	El.En S.P.A.	accessdata.fda.gov
January 4, 2023	K222221	DEKA HELIX	GEX	Substantially Equivalent	El.En Electronic Engineering Spa	accessdata.fda.gov
June 2, 2022	K213261	EpilME	GEX	Substantially Equivalent	Neauvia North America	accessdata.fda.gov
October 21, 2021	K212270	DEKA LipoAI	GEX	Substantially Equivalent	El.En Electronic Engineering Spa	accessdata.fda.gov
January 15, 2016	K150409	VIVACE Electrosurgical System	OUH	Substantially Equivalent	Sung Hwan E&B Co.,Ltd	accessdata.fda.gov

Compare with other makers

Updated November 21, 2024. 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.