đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA record identifies the device under product code OHS and cleared it through the 510(k) pathway.
- The available record supports use as an LED light-therapy device for labeled clinical applications.
- The supplied FDA indications summary does not provide a specific disease, wavelength, body site, or treatment protocol.
Clinical Applications
- Noninvasive LED light treatments performed by trained healthcare professionals.
- Clinical light-therapy applications in settings covered by the device's manufacturer labeling.
- Use in outpatient clinical environments when the device is operated according to its FDA-cleared labeling and instructions for use.
Practical Considerations
- The available record does not specify the device's wavelengths, irradiance, treatment-head dimensions, or treatment protocols; these should be confirmed in the current manufacturer instructions for use.
- Use only according to the FDA-cleared labeling, manufacturer instructions, and facility protocols.
- The supplied record does not establish MRI safety. Do not bring the device into an MRI environment unless its labeling specifically addresses MRI compatibility.
- Review patient-specific contraindications and precautions in the manufacturer labeling, including risks related to photosensitivity or photosensitizing medications.
- The device is a light-therapy system rather than an intravascular or implantable device; no vessel access or implantation is described.
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.