Atlas FDA

NUV

19 FDA 510(k) clearances · Product code

113 daysmedian time to decision
234 days90th percentile
19clearances measured

FDA profile

Official device name
Massager, Vacuum, Light Induced Heating
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4810
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
FDA definition
The device is intended to temporarily alter the appearance of cellulite
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RecordFirmDate
T-SHAPE 2 (K231092)B&M S.R.L. Marketing Nel Benessere2023-09-22
ICOONE Laser Med (also referred to as ICOONE Medical laser) (K211272)I-Tech Industries Srl2021-06-22
ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) (K182453)I-Tech Industries Srl2019-01-11
Slimming Treatment Device (K161892)Beijing Honkon Technologies Co., Ltd.2017-03-02
INMODE WMBODY DEVICE (K131362)Inmode MD , Ltd.2013-10-08
VELASHAPE (K122579)Syneron Medical, Ltd.2012-09-13
MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM (K101147)Alma Lasers, Inc.2011-01-21
I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) (K101366)Chromogenex Technologies, Ltd.2010-09-17
SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V (K100230)Eleme Medical, Inc.2010-04-02
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (K092195)Cutera, Inc.2009-10-01
REACTION SYSTEM (K090221)Viora , Ltd.2009-07-01
SMOOTHSHAPES (K083629)Eleme Medical, Inc.2009-02-19
ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE (K082622)Alma Lasers , Ltd.2009-01-12
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (K080300)Cutera, Inc.2008-04-08
VELASHAPE (K071872)Syneron Medical, Ltd.2007-08-22
MODIFICATION TO VELASMOOTH, SHAPER (K070092)Syneron Medical, Ltd.2007-07-27
SMOOTHSHAPES (K061603)Biocellulase, Inc.2006-07-03
SMOOTHSHAPES (K053611)Bicellulase, Inc.2006-03-15
VELASMOOTH, SHAPER (K050397)Syneron Medical, Ltd.2005-06-09

Track NUV automatically

Every clearance here is in the API, with alerts when new ones post.