When it comes to purchasing personal care and wellness devices, safety and regulatory approval are top concerns for many consumers. One of the most frequently asked questions about Megelin products is whether they are FDA approved. Let's clear up any confusion.

1. Megelin IPL Hair Removal Device - FDA Approved

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

• 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 is crucial for ensuring that the IPL Hair Removal Device meets the safety and effectiveness standards required by the FDA for over-the-counter use. It demonstrates that the device has undergone thorough evaluation and is safe for consumer use in the United States.

2. Megelin Red Light Therapy Devices - Manufactured by FDA Registered Suppliers- Safe and Effective

While not all Megelin products require FDA approval, we take your safety seriously. Our red light therapy devices fall under the classification of "LAMP, INFRARED, THERAPEUTIC HEATING," which is a Class II medical device category. Here are the specifics:

• Classification Name: LAMP, INFRARED, THERAPEUTIC HEATING
• Product Code: ILY
• Device Class: 2
• Proprietary Name: 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 device, these products are considered low-risk and do not require a 510(k) number. However, Megelin still chooses to work with FDA registered manufacturers to ensure that our devices are produced under stringent quality control standards. This commitment to quality ensures that you are receiving a high-quality, safe, and effective product, even if it doesn't require specific FDA approval.