Identifiers
- 510(k) Number
- K123407 FDA 510(k)
- FDA Product Code
- OYW 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 Cellulaze Laser is a laser device indicated for the treatment of cellulite appearance. It functions by targeting the structural causes of cellulite beneath the skin to address the condition at its source.
This device is a minimally invasive procedure that has received FDA 510k clearance. It is intended for use by practitioners in a clinical setting to treat mild to moderate cellulite on the thighs of patients who are not significantly overweight.
Frequently asked questions
What is the primary indication for the Cellulaze Laser?
The Cellulaze Laser is indicated for the treatment of cellulite appearance. It is specifically designed for use on the thighs of patients who are not significantly overweight and present with mild to moderate cellulite.
How does the Cellulaze Laser function to treat cellulite?
The device functions by targeting the structural causes of cellulite beneath the skin. By addressing these underlying factors at their source, the laser works to improve the appearance of the skin in the treated area.
What is the regulatory status of the Cellulaze Laser?
The Cellulaze Laser has received FDA 510k clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices for its intended use.
Who is the intended user of this laser device?
The Cellulaze Laser is intended for use by practitioners within a clinical setting. It is a minimally invasive procedure that requires professional administration to ensure it is used appropriately for the indicated patient population.
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: Minimally Invasive Cellulite Treatment - Cellulaze® - Cynosure, Cellulite Laser Treatment - Minimally Invasive - Cynosure, Cellulaze Cellulite Treatment Review: Does It Work?, Is Cellulaze Worth It? See Reviews, Cost, Pictures | RealSelf
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123407 | Class II | Active |
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Manufacturer
- Manufacturer
- Cynosure, Inc.
Sources (1)
- FDA 510(k) K123407 24 fields · synced Sep 21, 2026