510(k) K150212
K150212 is an FDA 510(k) premarket notification submitted by On Light Sciences, Inc. for the device "DeScribe Transparent PFD Patch". The FDA issued a decision of Substantially Equivalent on Apr 20, 2015. The device falls under product code PKO (Transparent Patch For Use In Treatment Of Tattoos), a Class II device regulated under 21 CFR 878.4810.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 20, 2015
- Date Received
- Jan 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
- 510(k)
To reduce formation of bubbles during laser treatment of tattoos.