QCY
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Laser Absorbing Particles
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Medical specialty
- General, Plastic Surgery
- FDA definition
- Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| SNA-001 Silver Photoparticle Topical Gel (K192620) | Sienna Biopharmaceuticals, Inc. | 2020-08-12 | + Add |
| Sebacia Microparticles (K181518) | Sebacia, Inc. | 2018-09-06 | + Add |
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Every clearance here is in the API, with alerts when new ones post.