510(k) K081570
K081570 is an FDA 510(k) premarket notification submitted by Led Technologies, LLC for the device "DPL THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 7, 2008. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Led Technologies, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2008
- Date Received
- June 4, 2008
- 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