FDA product code OZC: Over The Counter Thermal Treatment For Acne.
OZC is the FDA product code for over the counter thermal treatment for acne.. It is a Class II device, regulated under 21 CFR 890.5740 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under OZC. The average 510(k) review took 293 days (median 293).
Definition
For the treatment of mild to moderate inflammatory acne.
Classification
| Field | Value |
|---|---|
| Device name | Over The Counter Thermal Treatment For Acne. |
| Device class | Class II |
| Regulation | 21 CFR 890.5740 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OZC clearance
Top OZC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medicon Co., Ltd. | 1 | 2012-02-29 |
Most recent OZC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111341 | Medicon Co., Ltd. | CLEANE / CLEANE POP | 2012-02-29 | 293 |
Recalls for OZC devices
openFDA lists no recalls for product code OZC.
Frequently asked questions
What is FDA product code OZC?
OZC is the FDA product code for over the counter thermal treatment for acne.. It is a Class II device, regulated under 21 CFR 890.5740 and reviewed by the General and Plastic Surgery panel.
What device class is OZC?
Class II, regulation 21 CFR 890.5740. Typical premarket route: 510(k).
How long does a 510(k) take for product code OZC?
Across 1 cleared submissions the average was 293 days from receipt to decision (median 293).
Which companies have the most OZC clearances?
Medicon Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OZC
- Run a recall and safety report across every OZC manufacturer
- Watch product code OZC 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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