Avéli
by Revelle Aesthetics, Inc. 2 variants
510(k) K232153
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232153 | Date18 Aug 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OUP
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4790
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Avéli is a Powered Surgical Instrument for Improvement in the Appearance of Cellulite, classified as a Class II medical device under FDA regulation 878.4790. It is designed to target and reduce the visual severity of cellulite through controlled energy delivery, targeting subcutaneous tissue to improve skin texture and contour. The device operates under a Special 510(k) clearance with a focus on aesthetic improvement in plastic surgery settings.
The Avéli is intended for single-use and is supplied sterile, requiring no additional preparation beyond standard surgical protocols. It is non-MRI-compatible and must be stored in its original packaging until use. The device is authorized for use in outpatient clinics and aesthetic surgery centers, with no reusable components. Authorizations include FDA 510(k) clearance (K232153) under the OpenFDA product code OUP, with registration numbers 3043011436 and others listed in the regulatory database.
Other devices from Revelle Aesthetics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of clinical settings can use the Avéli device, and why is it designed for single-use?
The Avéli is authorized for use in outpatient clinics and aesthetic surgery centers, specifically within plastic surgery settings. It is designed for single-use to ensure sterility and reduce the risk of cross-contamination, requiring no additional preparation beyond standard surgical protocols. Since it is supplied sterile in its original packaging, this design aligns with best practices for minimizing infection risks in cosmetic procedures.
How should the Avéli device be stored before use, and what precautions should be taken?
The Avéli must be stored in its original packaging until use to maintain sterility. It is also non-MRI-compatible, so it should be kept away from MRI environments to avoid interference or damage. Proper storage ensures the device remains functional and safe for its intended aesthetic application.
Is the Avéli device reusable, and if not, what does this mean for cost and maintenance?
No, the Avéli is explicitly designed for single-use only, with no reusable components. This means each device is intended for one procedure, which simplifies sterilization processes and reduces the risk of contamination. Clinicians should account for the cost of a new device per use rather than maintenance or reprocessing expenses.
What regulatory pathway does the Avéli follow, and what does this mean for its use in clinical practice?
The Avéli received FDA clearance through a Special 510(k) pathway, classified as a Class II device under regulation 878.4790. This clearance confirms it meets FDA standards for safety and effectiveness in improving the appearance of cellulite through controlled energy delivery. Clinicians can rely on this authorization when using it in plastic surgery settings, as it aligns with established regulatory guidelines for aesthetic devices.