FDA product code PKO: Transparent Patch For Use In Treatment Of Tattoos
PKO is the FDA product code for transparent patch for use in treatment of tattoos. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under PKO, from 2 different applicants. The average 510(k) review took 82 days (median 82).
Definition
To reduce formation of bubbles during laser treatment of tattoos.
Classification
| Field | Value |
|---|---|
| Device name | Transparent Patch For Use In Treatment Of Tattoos |
| Device class | Class II |
| Regulation | 21 CFR 878.4810 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for PKO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 84 |
Compare with all 510(k) review times · Search every PKO clearance
Top PKO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Merz North America, Inc. | 1 | 2017-11-29 |
| On Light Sciences, Inc. | 1 | 2015-04-20 |
Most recent PKO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172689 | Merz North America, Inc. | DESCRIBE PFD Patch | 2017-11-29 | 84 |
| K150212 | On Light Sciences, Inc. | DeScribe Transparent PFD Patch | 2015-04-20 | 80 |
Recalls for PKO devices
openFDA lists no recalls for product code PKO.
Frequently asked questions
What is FDA product code PKO?
PKO is the FDA product code for transparent patch for use in treatment of tattoos. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel.
What device class is PKO?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code PKO?
Across 2 cleared submissions the average was 82 days from receipt to decision (median 82).
Which companies have the most PKO clearances?
Merz North America, Inc. (1); On Light Sciences, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PKO
- Run a recall and safety report across every PKO manufacturer
- Watch product code PKO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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