FDA Status

Is UVIVA FDA Approved?

When purchasing personal care and wellness devices, safety and regulatory approval are critical concerns. One of the most common questions regarding UVIVA products is whether they are FDA approved. Let’s break it down for clarity.

1. IPL Hair Removal Device - FDA Approved

Yes, the IPL (Intense Pulsed Light) Hair Removal Device is FDA approved. This approval is supported by a 510(k) number, essential for devices classified under "Light Based Over-The-Counter Hair Removal." Below are the details:

  • Device Classification Name: Light Based Over-The-Counter Hair Removal
  • 510(k) Number: K231800
  • Device Name: IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

The 510(k) number confirms that the IPL Hair Removal Device complies with FDA safety and effectiveness standards for over-the-counter consumer use. This evaluation ensures that the product is both safe and effective for use in the United States.

2. Red Light Therapy Devices - Manufactured by FDA Registered Suppliers

Not all products require FDA approval, but the brand prioritizes safety and quality. UVIVA's red light therapy devices fall under the classification "LAMP, INFRARED, THERAPEUTIC HEATING," a Class II medical device category. Here are the specifics:

  • Classification Name: LAMP, INFRARED, THERAPEUTIC HEATING
  • Product Code: ILY
  • Device Class: 2
  • Proprietary Names: LED FACE MASK; LED Therapy Light/LED (YD001 YD002 YD003 YD004 YD005 YD006 YD007 YD008 YD009 YD010 YD011 YD012 YD013 YD014 YD015 YD016; YD017 YD018 YD109; LLD001 LLD002 LLD003 LLD004 LLD005 LLD006 LLD007 LLD008 YD050 YD056 YD079 RXN04 RXH06 RXY07); Z2, Z2Pro
  • Owner/Operator Number: 10082798

As a Class II medical device, these products are considered low-risk and do not require a 510(k) number. However, UVIVA partners with FDA registered manufacturers to ensure compliance with stringent quality standards. This commitment guarantees that even non-FDA-approved products meet high safety and performance benchmarks.

UVIVA's dedication to safety and quality ensures peace of mind for its customers, making it a trusted choice for personal care and wellness devices.