510(k) K172689
K172689 is an FDA 510(k) premarket notification submitted by Merz North America, Inc. for the device "DESCRIBE PFD Patch". The FDA issued a decision of Substantially Equivalent on November 29, 2017. 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
- November 29, 2017
- Date Received
- September 6, 2017
- 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.