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U.S. Department of Health and Human Services

Product Classification

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Device laser absorbing particles
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy.
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 Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQCY
Premarket Review Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4810
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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