Transparent Patch For Use In Treatment Of Tattoos
The Transparent Patch For Use In Treatment Of Tattoos (product code PKO) is a Class 2 general and plastic surgery device used to reduce the formation of bubbles during laser treatment of tattoos, regulated under 878.4810. It requires 510(k) clearance to demonstrate substantial equivalence. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PKO
- Device Class
- FDA class 2
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
To reduce formation of bubbles during laser treatment of tattoos.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.