510(k) K090008
K090008 is an FDA 510(k) premarket notification submitted by Pharos Life Corporation for the device "TANDA RESTORE, MODEL PTSCS". The FDA issued a decision of Substantially Equivalent on October 15, 2009. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Pharos Life Corporation has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2009
- Date Received
- January 2, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Lamp, Infrared, Therapeutic Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type