510(k) K150212
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2015
- Date Received
- January 30, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transparent Patch For Use In Treatment Of Tattoos
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
To reduce formation of bubbles during laser treatment of tattoos.