510(k) K151333
K151333 is an FDA 510(k) premarket notification submitted by Led Intellectual Properties, LLC for the device "LightStim for Pain LED Belt". The FDA issued a decision of Substantially Equivalent on August 21, 2015. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Led Intellectual Properties, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2015
- Date Received
- May 19, 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