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elevare perfectio 4
Omm Imports D/B/A Zero Gravity
Summary: The Elevare Perfectio 4 is a Class 2 medical device cleared by the FDA for specific clinical applications. It is used by healthcare professionals in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K172909 ↗
Decision Date
June 7, 2018
Product Code
OHS
Device Class
Class 2
Evidence
0 studies
The Elevare Perfectio 4 was cleared through the FDA 510(k) pathway on June 7, 2018. Manufactured by Omm Imports, it is classified as a Class 2 device under product code OHS.
What It Is
The Elevare Perfectio 4 is a medical device designed to deliver therapeutic light energy. It utilizes LED technology to provide non-invasive treatment options for various conditions. The device is engineered to enhance cellular activity and promote healing, making it a valuable tool in clinical settings.
Clinical Applications
This device is commonly used in dermatology and cosmetic practices for skin rejuvenation and healing. It is suitable for outpatient settings and can be used on a wide range of patient populations, including those seeking non-invasive treatment options for skin conditions. The device's versatility makes it applicable in both aesthetic and therapeutic scenarios.
Indications for Use
The FDA-cleared indications suggest that the Elevare Perfectio 4 is intended for use in enhancing skin health and promoting healing. It is suitable for patients with conditions that benefit from light therapy, such as certain dermatological issues.
Practical Considerations
The device is typically compact and easy to use, making it suitable for various clinical environments. It is important to follow the manufacturer's guidelines for optimal results and ensure compatibility with existing clinical protocols.
Frequently Asked Questions
What is Elevare Perfectio 4 used for?
The device is used for delivering therapeutic light energy to enhance skin health and promote healing.
What specialties typically use this device?
Dermatology and cosmetic specialties commonly use this device for skin rejuvenation and healing.
What are the FDA-cleared indications?
The device is cleared for use in promoting skin health and healing through light therapy.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.