Laser Absorbing Particles
The Laser Absorbing Particles are surgical particles applied to target tissue for the purpose of absorbing laser or light energy during surgical procedures, enabling more controlled and localized energy delivery. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QCY under regulation 878.4810 in the General and Plastic Surgery specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QCY
- Device Class
- FDA class 2
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.