510(k) K131362
- Device
- INMODE WMBODY DEVICE
- Applicant
- INMODE MD LTD.
- 510(k) number
- K131362
- Product code
- NUV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-10-08
- Date received
- 2013-05-13
- 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
- AHAVA STEIN
- Address
- 20 Hata'As St., Suite 102 Kfar Saba IL 44425 44425
FDA Registration Numbers#
- 3006716777
- 3002808227
- 3013517454
- 3034995492
- 3010511300
- 3007712511
- 3013917867
- 3008729892
- 3011782009
- 3009736547
- 3009488834
- 3003015433
- 3006807694
- 3017132875
- 1222993
- 3025104654
- 3005695724
- 3004167969
- 3013539104
- 3016496662
Source Documents#
Other 510(k) Records For Product Code NUV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231092 | T-SHAPE 2 | B&M S.R.L. Marketing Nel Benessere | 2023-09-22 |
| K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser) | I-Tech Industries Srl | 2021-06-22 |
| K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) | I-Tech Industries Srl | 2019-01-11 |
| K161892 | Slimming Treatment Device | Beijing Honkon Technologies Co., Ltd. | 2017-03-02 |
| K122579 | VELASHAPE | Syneron Medical, Ltd. | 2012-09-13 |
| K101147 | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM | Alma Lasers, Inc. | 2011-01-21 |
| K101366 | I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010-09-17 |
| K100230 | SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V | Eleme Medical, Inc. | 2010-04-02 |
| K092195 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | 2009-10-01 |
| K090221 | REACTION SYSTEM | Viora , Ltd. | 2009-07-01 |
| K083629 | SMOOTHSHAPES | Eleme Medical, Inc. | 2009-02-19 |
| K082622 | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE | Alma Lasers , Ltd. | 2009-01-12 |
| K080300 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | 2008-04-08 |
| K071872 | VELASHAPE | Syneron Medical, Ltd. | 2007-08-22 |
| K070092 | MODIFICATION TO VELASMOOTH, SHAPER | Syneron Medical, Ltd. | 2007-07-27 |
Legacy Summary#
summary
FDA Review#
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