510(k) K121487
K121487 is an FDA 510(k) premarket notification submitted by Litecure, LLC for the device "LITECURE THERAPY COMPACT". The FDA issued a decision of Substantially Equivalent on June 12, 2012. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Litecure, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2012
- Date Received
- May 18, 2012
- Clearance Type
- Special
- 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