FDA product code QCY: Laser Absorbing Particles
QCY is the FDA product code for laser absorbing particles. 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 QCY, from 2 different applicants. The average 510(k) review took 207 days (median 207).
Definition
Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy.
Classification
| Field | Value |
|---|---|
| Device name | Laser Absorbing Particles |
| 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 QCY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 90 |
| 2020 | 1 | 324 |
Compare with all 510(k) review times · Search every QCY clearance
Top QCY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sienna Biopharmaceuticals, Inc. | 1 | 2020-08-12 |
| Sebacia, Inc. | 1 | 2018-09-06 |
Most recent QCY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192620 | Sienna Biopharmaceuticals, Inc. | SNA-001 Silver Photoparticle Topical Gel | 2020-08-12 | 324 |
| K181518 | Sebacia, Inc. | Sebacia Microparticles | 2018-09-06 | 90 |
Recalls for QCY devices
openFDA lists no recalls for product code QCY.
Frequently asked questions
What is FDA product code QCY?
QCY is the FDA product code for laser absorbing particles. 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 QCY?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code QCY?
Across 2 cleared submissions the average was 207 days from receipt to decision (median 207).
Which companies have the most QCY clearances?
Sienna Biopharmaceuticals, Inc. (1); Sebacia, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QCY
- Run a recall and safety report across every QCY manufacturer
- Watch product code QCY 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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