Definition: Particles Are Applied To The Target Tissue(s) For The Purpose Of Absorbing Laser/light Energy.
| Device Type ID | 5908 |
| Device Name | Laser Absorbing Particles |
| Physical State | Particles Are Made Of Material(s) That Is Inert Before And After Heating With Laser Light. Black Body Absorber. |
| Technical Method | Particles Are Designed To Absorb Certain Laser/light Wavelength(s) To Create Heat In The Particle. |
| Target Area | Skin In And Around Acne Lesions, Or Hair Follicles. |
| Regulation Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4810 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QCY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |