Fractora
510(k) K102461
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102461 | Date2 Jun 2011 | 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- Withdrawn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
- FDA applicant
- Invasix , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Fractora is an electrosurgical device designed for cutting and coagulation procedures, classified under the category of electrosurgical cutting and coagulation accessories. It is intended for use in plastic surgery applications, delivering controlled energy to facilitate tissue manipulation and enhancement of aesthetic outcomes.
The Fractora is supplied as a reusable device and is regulated under FDA 510(k) clearance (K102461) with a Traditional review pathway. It is intended for use in clinical settings, adhering to standard surgical protocols, and is not specified as MRI-safe or single-use. No additional sterility or storage instructions are provided beyond standard medical device handling.
Questions
AI-generated answers, 19 Sep 2026
What types of plastic surgery procedures is the Fractora designed to assist with, and how does it achieve this?
The Fractora is specifically designed for cutting and coagulation procedures in plastic surgery. It delivers controlled electrosurgical energy to facilitate precise tissue manipulation, helping to enhance aesthetic outcomes during surgical interventions. This dual functionality allows surgeons to both cut and seal tissues efficiently, reducing bleeding and improving surgical control.
Is the Fractora a single-use device, or can it be reused in multiple procedures? Why does this matter?
The Fractora is a reusable device, meaning it can be used across multiple procedures after proper cleaning and maintenance. This matters because reusable devices can offer cost savings in the long run for healthcare facilities, provided they adhere to strict reprocessing protocols to ensure safety and functionality. However, reuse requires adherence to standard medical device handling and sterilization procedures.
What regulatory pathway was followed for the Fractora’s FDA clearance, and what does this mean for its use in clinical settings?
The Fractora received FDA clearance through the 510(k) pathway, specifically under the Traditional review process with a decision code of SESE (Substantially Equivalent). This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards. Clinically, this clearance indicates the device adheres to standard surgical protocols and is approved for use in controlled medical environments.
Are there any special storage instructions for the Fractora beyond standard medical device handling?
The provided documentation does not specify any special storage instructions for the Fractora beyond standard medical device handling. This means it should be stored in a clean, dry environment, protected from physical damage, and following general guidelines for reusable surgical equipment to maintain its functionality and safety for repeated use.