Finesse System
510(k) K072261
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072261 | Date26 Dec 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Finesse System is a radiofrequency (RF) electrosurgical generator designed for dermatologic and general surgical procedures. It delivers controlled RF energy for electrocoagulation and hemostasis, facilitating tissue treatment with precision. The device operates via disposable electrode cartridges and a reusable electrode insertion system, enabling versatile applications in surgical settings. Its classification aligns with the General, Plastic Surgery advisory committee under the FDA’s GEI (General and Plastic Surgery Instruments) product code.
The Finesse System is supplied as a reusable generator paired with single-use electrode cartridges, ensuring sterility and compliance with surgical standards. It is intended for use in controlled environments such as operating rooms or procedural suites, where RF energy is applied to achieve hemostasis or tissue modification. The system’s FDA 510(k) clearance (K072261) confirms its substantial equivalence to predicate devices like the Thermage ThermaCool and Radionics Cool-Tip RF systems. No MRI safety or size-specific storage instructions are documented in the regulatory submission.
Other devices from Primaeva Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Finesse System used for in surgical settings?
The Finesse System is designed for dermatologic and general surgical procedures, providing controlled radiofrequency (RF) energy to achieve electrocoagulation and hemostasis. It enables precise tissue treatment, making it suitable for applications like skin resurfacing, lesion removal, or vascular occlusion in controlled environments such as operating rooms or procedural suites.
How is the Finesse System supplied and what does this mean for sterility?
The Finesse System consists of a reusable RF generator paired with single-use electrode cartridges. This design ensures sterility for each procedure, as the cartridges are intended for one-time use, eliminating the need for reprocessing and reducing infection risks in surgical settings.
Is the Finesse System approved for MRI environments?
The regulatory submission for the Finesse System does not include any documentation regarding MRI safety. Clinicians should verify compatibility with their specific MRI systems before use, as the device’s materials or components may not have been tested or cleared for MRI environments.
What distinguishes the Finesse System from other RF generators?
The Finesse System is FDA 510(k)-cleared (K072261) as substantially equivalent to predicate devices like the Thermage ThermaCool and Radionics Cool-Tip RF systems. Its distinguishing feature is the use of disposable electrode cartridges paired with a reusable generator, enabling versatile surgical applications while maintaining sterility standards.
Are there specific storage requirements for the Finesse System?
The regulatory submission does not specify size-specific storage instructions or special handling for the Finesse System generator or cartridges. However, standard environmental controls (e.g., temperature, humidity) should be maintained to preserve functionality. Single-use cartridges should be stored according to manufacturer guidelines until use.