QCY — Laser Absorbing Particles Class II
FDA product code QCY covers "Laser Absorbing Particles", a Class II medical device regulated under 21 CFR 878.4810. Submissions are reviewed by the General, Plastic Surgery panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QCY
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy.