Reverso Pro System
by Indiba S.A.U. Spain 510(k)
510(k) K243139
Product code GEI
Overview
The Reverso Pro System is a fractional radiofrequency (RF) device classified under the nomenclature for non-invasive dermatologic procedures. It delivers controlled thermal energy to the skin for targeted skin resurfacing, promoting collagen remodeling and tissue regeneration. Designed for precision, it employs fractional RF technology to treat superficial and deeper skin layers while minimizing surface trauma. Its primary function is to improve skin texture, tone, and appearance in dermatologic and cosmetic applications.
The Reverso Pro System is supplied as a reusable medical device, intended for use in clinical settings such as dermatology clinics and plastic surgery offices. It operates with disposable applicator tips, ensuring sterility and single-use compliance per procedural requirements. The device is FDA-cleared under 510(k) classification (K243139) for general and plastic surgery applications, adhering to regulatory standards for non-invasive skin treatments. Storage and handling follow manufacturer guidelines to maintain performance and sterility, with no specific MRI safety restrictions noted.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK243139 | Date22 Jan 2025 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- FDA applicant
- Indiba S. A. U.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
Discover INDIBA® Reverso, the Fractional RF device for efficient, patient-tailored skin resurfacing. Customizable treatments, impressive results, and award-winning design.
Reverse Skin Aging Deep Reverso is a Fractional RF device, offering highly efficient, patient- tailored skin resurfacing. The device incorporates several innovative technological solutions, all intended to guarantee optimal clinical results while maintaining the utmost safety.
Manufacturer's product page: Reverso
Other devices from Indiba S.A.U.
Questions
What types of clinical settings is the Reverso Pro System intended for, and how is it typically used there?
The Reverso Pro System is designed for clinical settings like dermatology clinics and plastic surgery offices. It’s a reusable device that delivers fractional radiofrequency (RF) energy to the skin for non-invasive resurfacing, targeting superficial and deeper layers to improve texture, tone, and appearance. The system relies on single-use disposable applicator tips to ensure sterility per procedural requirements, making it suitable for controlled environments where precision and hygiene are critical.
Are the applicator tips for the Reverso Pro System meant to be reused, and if not, why?
No, the applicator tips for the Reverso Pro System are intended for single-use only. This design choice ensures sterility and compliance with procedural standards, reducing the risk of cross-contamination between patients—a critical factor in dermatologic and cosmetic treatments where infection control is paramount.
What kind of maintenance or storage guidelines should I follow for the Reverso Pro System to keep it functional and sterile?
The Reverso Pro System must be stored and handled according to the manufacturer’s guidelines to preserve performance and sterility. Since it’s a reusable device, proper cleaning and maintenance protocols are essential, though specific details like cleaning agents or storage conditions aren’t provided in the data. Always follow the instructions included with the device to avoid compromising its functionality or regulatory compliance.
Does the Reverso Pro System have any restrictions on use in environments with MRI machines?
The data does not mention any specific MRI safety restrictions for the Reverso Pro System, meaning it may not contain metallic components or materials that would pose a risk in an MRI environment. However, it’s always best to verify with the manufacturer or consult their technical documentation to ensure safe operation near MRI equipment, as potential risks could depend on how the device is used or modified.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K243139