Capenergy C100, C200, C300, C400, C50
by Capenergy Medical S.L. EUDAMED510(k)
Active
510(k) K191202
Overview
The Capenergy C100, C200, C300, C400, and C50 are Vacuum, Radio Frequency Induced Heat Massagers, designed to promote tissue remodeling and healing through controlled suction and thermal energy. These devices are intended for use in general and plastic surgery procedures, aiding in the reduction of fibrosis, scar tissue, and edema while improving tissue elasticity and vascularization.
These massagers are supplied as reusable, non-sterile devices, intended for use in clinical settings such as operating rooms or recovery areas. They are classified as Class II medical devices under FDA regulations and comply with the Medical Devices Directive (MDD). Each model (C100, C200, C300, C400, C50) may vary in suction intensity and thermal output, as specified in the manufacturer’s instructions. No MRI safety information is provided, and proper sterilization procedures must be followed if reused.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK191202 | Date11 Feb 2020 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- PBX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Capenergy Medical S.L.
Questions
Are the Capenergy C100–C50 devices single-use or reusable, and what does that mean for my clinical workflow?
The Capenergy C100, C200, C300, C400, and C50 are reusable devices designed for clinical settings like operating rooms or recovery areas. Since they are not sterile as shipped, they require proper sterilization between uses to maintain safety and hygiene. This means your facility must follow established reprocessing protocols, including cleaning, disinfection, and sterilization, to ensure safe reuse across multiple patients.
What clinical benefits do these massagers provide, and how do they differ from traditional massage techniques?
These devices combine vacuum suction and radiofrequency-induced heat to promote tissue remodeling, reducing fibrosis, scar tissue, and edema while improving elasticity and vascularization. Unlike manual massage, they deliver controlled thermal and mechanical energy to deeper tissue layers, which may accelerate healing and enhance outcomes in general and plastic surgery procedures. The varying models (C100–C50) offer different suction intensities and thermal outputs, allowing customization for specific patient needs.
Do these devices have any restrictions on where they can be used in my facility, such as proximity to MRI machines?
The manufacturer does not provide MRI safety information for the Capenergy C100–C50 devices. This means you should assume they are not MRI-compatible unless explicitly verified by the manufacturer. Always check with your facility’s MRI safety officer before using them near MRI equipment to avoid potential interference or safety risks.
How do I know which model (C100, C200, etc.) is right for my patients, and are there differences in their performance?
The models differ primarily in suction intensity and thermal output, as outlined in the manufacturer’s instructions. The C100 likely offers the lowest intensity, while the C50 (and potentially others) may provide higher settings for more advanced tissue remodeling. The choice depends on your clinical goals—whether you need gentle stimulation for early-stage healing or stronger therapy for dense fibrosis. Consult the manufacturer’s documentation or a representative to match the device to your specific patient needs.