510(k) K152280
K152280 is an FDA 510(k) premarket notification submitted by Biophotas, Inc. for the device "BioPhotas Celluma3". The FDA issued a decision of Substantially Equivalent on March 2, 2016. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Biophotas, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2016
- Date Received
- August 12, 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