PKO — Transparent Patch For Use In Treatment Of Tattoos Class II
FDA product code PKO covers "Transparent Patch For Use In Treatment Of Tattoos", a Class II medical device regulated under 21 CFR 878.4810. Submissions are reviewed by the General, Plastic Surgery panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- PKO
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- 510(k)
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
To reduce formation of bubbles during laser treatment of tattoos.