Is LUMYHEALTH™ FDA Approved?

Safety and regulatory approval are key considerations for consumers when purchasing personal care and wellness devices. A common question about LUMY HEALTH™ products is whether they have FDA approval. Let’s address this concern directly.

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

While not all LUMYHEALTH™ 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:
  • Red light therapy for body: L1-L10, L1S-L10s,L105,L120,L140,L150,L180, L300-L900, L100S-L900S
  • Hair treatment device: BP-L1, BP206, BP1932, BP206, L81, L108, L200, L266, T100-T900

  • Led face mask: L100, MY210, M100-M900, M100S-M900S

  • Red light therapy: LS-D802,BP-016,B1,B2,B3,B3A,B5,B6,B7,B8,B9,B1

    0,B1S,B2S,B3S,B5S,B6S,B7S,B8S,B9S,B10S

Owner/Operator Number:10089647

As Class II devices, these products are classified as low-risk and do not require a 510(k) clearance. However, LUMYHEALTH™ partners with FDA-registered manufacturers to guarantee that all devices are made under strict quality control standards. This dedication to excellence ensures you receive a safe, reliable, and effective product, even without the necessity of specific FDA approval.