Massager, Vacuum, Light Induced Heating
General, Plastic Surgery · 21 CFR 878.4810
The device is intended to temporarily alter the appearance of cellulite
Recent MDR events
10 adverse event reports on file
- VELASHAPE IIIAug 26, 2020InjurySyneron Medical Ltd.3003772750-2020-00003
- BTL ULTRAFEMME 360Dec 26, 2018InjuryBtl Industries, Inc.MW5082613
- BTL EXILIS ULTRA FEMME 360Oct 23, 2018Btl Industries Ltd.MW5080773
- VELASHAPE IIIMay 25, 2018InjurySyneron Medical Ltd.3003772750-2018-00001
- VELASHAPEAug 29, 2015InjurySyneronMW5055890
- VELASHAPE AND ULTRASHAPEMay 13, 2015InjurySyneron Medical Ltd3004772125-2015-00001
- BODY BENEFITS COMPACT HEATED MASSAGERDec 30, 2013InjuryConair Corp.1222304-2013-00014
- VELASHAPESep 25, 2012InjuryMW5027052
- VELASHAPESep 14, 2012InjurySyneron Medical Ltd.3004772125-2012-00004
- TRUSCULPTJun 13, 2012InjuryCutera, Inc.2954354-2012-00015
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
36 firms currently registered for this product code
Alma Lasers Ltd.
CAESAREA Northern, IL
Beijing Spiritlaser Science & Technology Co., Ltd.
Beijing, CN
Viora Ltd.
Migdal HaEmek Northern, IL
Cynosure, Llc
Westford, MA, US
Inmode Ltd.
Yokneam Northern, IL
Beijing Honkon Technologies Co., Ltd.
Beijing, CN
Preferred Depot
Irvine, CA, US
Sor Van Radiation Ltd
Yavne Tel Aviv, IL
B.y. Medimor Ltd
Tiberias Northern, IL
Usr Electronic Systems (1987) Ltd
Karmiel Northern, IL
Sharplight Technologies Ltd.
RISHON LEZION Tel Aviv, IL
Laser Marketing Group, Llc
Lehi, UT, US
Mediplast Israel Ltd
Yavne Tel Aviv, IL
I-tech Industries Srl
Bologna, IT
Cogmedix
West Boylston, MA, US
Candela Corporation
Marlborough, MA, US
510(k) clearances
19 clearances for this product code
- B&M S.R.L. Marketing Nel BenessereSep 22, 2023
K231092 · T-SHAPE 2
- I-Tech Industries SrlJun 22, 2021
K211272 · ICOONE Laser Med (also referred to as ICOONE Medical laser)
- I-Tech Industries SrlJan 11, 2019
K182453 · ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)
- Beijing Honkon Technologies Co., Ltd.Mar 2, 2017
K161892 · Slimming Treatment Device
- Inmode MD , Ltd.Oct 8, 2013
K131362 · INMODE WMBODY DEVICE
- Syneron Medical, Ltd.Sep 13, 2012
K122579 · VELASHAPE
- Alma Lasers, Inc.Jan 21, 2011
K101147 · MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
- Chromogenex Technologies, Ltd.Sep 17, 2010
K101366 · I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)