510(k) K151521
K151521 is an FDA 510(k) premarket notification submitted by Phoenix Thera-Lase Systems, LLC for the device "Phoenix Thera-Lase System". The FDA issued a decision of Substantially Equivalent on Sep 4, 2015. 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
- Sep 4, 2015
- Date Received
- Jun 5, 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
- 510(k) Exempt