Lipsonix System Model 2
by Medicis Technologies Corporation
510(k) K112626
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112626 | Date20 Oct 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- Withdrawn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
- Full name
- Lipsonix(R) System Model 2
- 510(k) Number
- FDA Product Code
- OHV
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4590
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Lipsonix System Model 2 is a focused ultrasound device designed for tissue heat or mechanical cellular disruption. Classified under FDA regulation 878.4590 as a Class II medical device, it employs ultrasound energy to target and treat subcutaneous fat deposits through controlled thermal or mechanical effects. This system is intended for use in non-invasive body contouring procedures, specifically within the domain of general and plastic surgery.
The device is supplied as a reusable medical system and requires appropriate sterilization procedures before use. It is intended for use in clinical settings where focused ultrasound technology is applied under professional supervision. The system’s regulatory clearance (FDA 510(k) K112626) confirms its substantial equivalence to a predicate device, adhering to safety and performance standards for focused ultrasound applications. No specific MRI safety information is provided, and its operational parameters align with the product code OHV under FDA classification.
Other devices from Medicis Technologies Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the Lipsonix System Model 2 used for?
The Lipsonix System Model 2 is designed for non-invasive body contouring procedures, specifically targeting subcutaneous fat deposits. It uses focused ultrasound energy to achieve controlled thermal or mechanical cellular disruption, helping to reshape and contour the body without surgical intervention. This technology is primarily applied in plastic and general surgery settings.
Is the Lipsonix System Model 2 single-use or reusable?
The Lipsonix System Model 2 is supplied as a reusable medical device. Before each use, it must undergo appropriate sterilization procedures to ensure safety and compliance with clinical standards. This design allows for repeated use in controlled environments, such as surgical or clinical settings.
What sterilization methods are recommended for the Lipsonix System Model 2?
Since the Lipsonix System Model 2 is reusable, it requires sterilization using methods approved for medical devices, such as autoclaving, ethylene oxide, or other validated sterilization techniques. The manufacturer’s instructions should be followed to ensure proper sterilization and maintain device integrity and safety for repeated use.
Does the Lipsonix System Model 2 have any specific MRI safety information?
The provided documentation does not include any specific MRI safety information for the Lipsonix System Model 2. Clinicians should exercise caution and verify compatibility with MRI equipment before use in environments where MRI scans are performed, as ultrasound devices may interact with magnetic fields.
What regulatory clearance does the Lipsonix System Model 2 hold?
The Lipsonix System Model 2 holds FDA 510(k) clearance under the classification K112626, confirming its substantial equivalence to a predicate device. This clearance aligns with FDA regulation 878.4590 and ensures the device meets safety and performance standards for focused ultrasound applications in non-invasive body contouring procedures.