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U.S. Department of Health and Human Services

Product Classification

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Device laser for disruption of adipocyte cells for aesthetic use
Regulation Description Low level laser system for aesthetic use
Definition Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Physical State The device may include up to three rectangular applicator heads with sapphire glass and dimensions of 4 cm x 6 cm. The laser may be 1064 nm and range in power density from 0.9-1.4 W/cm2.
Technical Method Laser energy is delivered to the adipose tissue to elevate temperature to 42-47 C for disruption of adipocyte cells. Subsequently, the adipocyte cells release fat and lipids resulting in reduction of the adipose tissue.
Target Area Areas of the body for treatment such as the flank, abdomen, thighs, waist, hips
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePKT
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.5400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible