Cutera Multimodal Cellulite Product (CMMCD)
FDA 510(k)Class II (US FDA 510(k))
by Cutera, Inc.
Identifiers
- 510(k) Number
- K080300 FDA 510(k)
- FDA Product Code
- NUV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cutera Multimodal Cellulite Product (CMMCD) is a Class 2 device that combines infrared and RF energies to provide topical heating for elevating tissue temperature. It is intended for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The device also includes a massage component intended to provide a temporary reduction in the appearance of cellulite.
The Cutera Multimodal Cellulite Product (CMMCD) is manufactured by Cutera, Inc. and is cleared through the Traditional 510(k) pathway with FDA clearance number K080300. The device is authorized for use in General and Plastic Surgery specialties with product code NUV. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the device data.
Frequently asked questions
What is the Cutera Multimodal Cellulite Product used for?
The CMMCD combines infrared and RF energies to provide topical heating for elevating tissue temperature. It is intended for treating selected medical conditions including relief of pain, muscle spasms, and increasing local circulation. It also includes a massage component for temporary reduction in cellulite appearance.
What is the regulatory status of the Cutera Multimodal Cellulite Product?
The CMMCD is a Class 2 device cleared through the Traditional 510(k) pathway with FDA clearance number K080300. It is authorized for use in General and Plastic Surgery specialties with product code NUV.
Is the Cutera Multimodal Cellulite Product sterile or single-use?
The device data does not provide information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions. These specifications would need to be obtained directly from the manufacturer or through additional regulatory documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (K080300) — FDA 510 (k ..., K080300 FDA 510(k) - CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD), CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (K092195) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080300 | Class II | Active |
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Manufacturer
- Manufacturer
- Cutera, Inc.
Sources (1)
- FDA 510(k) K080300 24 fields · synced Oct 1, 2026