510(k) K153389
K153389 is an FDA 510(k) premarket notification submitted by In Light Wellness Systems, Inc. for the device "Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)". The FDA issued a decision of Substantially Equivalent on March 30, 2016. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2016
- Date Received
- November 23, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Infrared, Therapeutic Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type