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510(k) K231092

Device
T-SHAPE 2
Applicant
B&M S.R.L. Marketing Nel Benessere
510(k) number
K231092
Product code
NUV
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-22
Date received
2023-04-18
Regulation
878.4810
Classification name
Massager, Vacuum, Light Induced Heating
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brando Baldan
Address
Via Leonardo Bruni, 25 Milano IT 20158 20158

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NUV#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl2021-06-22
K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl2019-01-11
K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.2017-03-02
K131362INMODE WMBODY DEVICEInmode MD , Ltd.2013-10-08
K122579VELASHAPESyneron Medical, Ltd.2012-09-13
K101147MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMAlma Lasers, Inc.2011-01-21
K101366I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.2010-09-17
K100230SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230VEleme Medical, Inc.2010-04-02
K092195CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)Cutera, Inc.2009-10-01
K090221REACTION SYSTEMViora , Ltd.2009-07-01
K083629SMOOTHSHAPESEleme Medical, Inc.2009-02-19
K082622ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULEAlma Lasers , Ltd.2009-01-12
K080300CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)Cutera, Inc.2008-04-08
K071872VELASHAPESyneron Medical, Ltd.2007-08-22
K070092MODIFICATION TO VELASMOOTH, SHAPERSyneron Medical, Ltd.2007-07-27