510(k) K170068
K170068 is an FDA 510(k) premarket notification submitted by Wellray Medical Laser, Inc. for the device "Softcure 96". The FDA issued a decision of Substantially Equivalent on May 5, 2017. 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
- May 5, 2017
- Date Received
- January 9, 2017
- 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