Smoothshapes System, 11318-120V, 11319-230V
FDA 510(k) K100230 · Eleme Medical, Inc.
510(k) numberK100230
Submission
- Device name
- Smoothshapes System, 11318-120V, 11319-230V
- Applicant
- Eleme Medical, Inc.
Merrimack, NH, US - Received
- January 26, 2010
- Decision date
- April 2, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUV – Massager, Vacuum, Light Induced Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
The device is intended to temporarily alter the appearance of cellulite
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| K101147 | Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemNUV · Traditional | Alma Lasers, Inc. | 01/21/2011SE |
| K101366 | I-Lipo, Models A00-1238 (230V), A00-1239 (120V)NUV · Traditional | Chromogenex Technologies, Ltd. | 09/17/2010SE |
| K092195 | Cutera Multimodal Cellulite Product (Cmmcd)NUV · Special | Cutera, Inc. | 10/01/2009SE |
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Questions and answers
When was Smoothshapes System, 11318-120V, 11319-230V cleared by the FDA?
Smoothshapes System, 11318-120V, 11319-230V (K100230) received a 510(k) decision of Substantially Equivalent on April 2, 2010, 66 days after the submission was received.
What is the product code of K100230?
The FDA product code is NUV – Massager, Vacuum, Light Induced Heating, a Class II (moderate risk) device regulated under 21 CFR 878.4810.