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 Nov 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
- Nov 29, 2017
- Date Received
- Sep 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
- 510(k)
To reduce formation of bubbles during laser treatment of tattoos.