truSculpt iD
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Cutera, Inc.
Identifiers
- 510(k) Number
- K223110 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The truSculpt iD is a non-invasive body contouring device designed for fat reduction and tissue tightening. Classified under the nomenclature for radiofrequency-based energy delivery systems, it employs controlled energy to selectively target and reduce subcutaneous fat while promoting collagen remodeling in the skin.
This device is intended for use in clinical settings by trained professionals and is supplied as a reusable system with disposable applicators. It is not MRI-safe and requires proper storage in a clean, dry environment. Authorized under FDA 510K clearance and MDD, the truSculpt iD operates under the product code GEI, with a special clearance designation for substantial equivalence in the field of general and plastic surgery.
Frequently asked questions
What types of clinical settings is the truSculpt iD intended for use in, and who should operate it?
The truSculpt iD is designed for use in clinical settings by trained professionals, specifically within the fields of general and plastic surgery. Its specialized clearance under the Substantial Equivalence (SESE) designation for radiofrequency-based energy delivery systems indicates it is meant for controlled, professional application by trained practitioners in these specialties.
Is the truSculpt iD system reusable, and what components are disposable?
Yes, the truSculpt iD is supplied as a reusable system, but it includes disposable applicators that must be replaced after each use. This design ensures hygiene and reduces cross-contamination risks in clinical settings.
What storage conditions are required for the truSculpt iD, and why?
The truSculpt iD must be stored in a clean, dry environment to maintain its functionality and ensure longevity. Proper storage conditions help prevent damage from moisture or contaminants, which could compromise performance or safety during use.
What regulatory pathways does the truSculpt iD follow, and what does this mean for its use?
The truSculpt iD is authorized under both FDA 510K clearance and the Medical Device Directive (MDD). Its clearance under the product code GEI (General and Plastic Surgery) and a Special Substantial Equivalence (SESE) designation confirms it meets regulatory standards for non-invasive body contouring devices, ensuring it is safe and effective for its intended professional use.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223110 | Class II | Active |
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Manufacturer
- Manufacturer
- Cutera, Inc.
Sources (2)
- FDA 510(k) K223110 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026