I-Lipo, Models A00-1238 (230V), A00-1239 (120V)
FDA 510(k) K101366 · Chromogenex Technologies, Ltd.
510(k) numberK101366
Submission
- Device name
- I-Lipo, Models A00-1238 (230V), A00-1239 (120V)
- Applicant
- Chromogenex Technologies, Ltd.
Llanelli, Carmarthenshire, GB - Received
- May 17, 2010
- Decision date
- September 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K122579 | VelashapeNUV · Special | Syneron Medical, Ltd. | 09/13/2012SE |
| K101147 | Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemNUV · Traditional | Alma Lasers, Inc. | 01/21/2011SE |
| K100230 | Smoothshapes System, 11318-120V, 11319-230VNUV · Special | Eleme Medical, Inc. | 04/02/2010SE |
| K092195 | Cutera Multimodal Cellulite Product (Cmmcd)NUV · Special | Cutera, Inc. | 10/01/2009SE |
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Questions and answers
When was I-Lipo, Models A00-1238 (230V), A00-1239 (120V) cleared by the FDA?
I-Lipo, Models A00-1238 (230V), A00-1239 (120V) (K101366) received a 510(k) decision of Substantially Equivalent on September 17, 2010, 123 days after the submission was received.
What is the product code of K101366?
The FDA product code is NUV – Massager, Vacuum, Light Induced Heating, a Class II (moderate risk) device regulated under 21 CFR 878.4810.