SMOOTHSHAPES
FDA 510(k) clearance K083629 · decided 2009-02-19
Clearance details
- K-number
- K083629
- Device name
- SMOOTHSHAPES
- Applicant
- Eleme Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-08
- Decision date
- 2009-02-19
- Days to decision
- 73 days
- Clearance type
- Special
- Product code
- NUV
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Merrimack, NH, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE (K082622) | Alma Lasers , Ltd. | 2009-01-12 |
Recalls involving this device
No recalls on record reference this clearance.