Erchonia FDA Approvals
k012580 PL3 – Chronic Neck and Shoulder Pain
K041139 EML – Laser Assisted Liposuction
K050672 EVRL – Acne
K072206_EML – Breast Augmentation
K082609 MLS – Non – Invasive Body Contouring
K121690 Zerona-AD – Arm Circumference
K130922 Verju Laser System – Body Contouring of the Waist, Hips, Thighs & Appearance of Cellulite
K132940 FX 635 Laser – Adjunct to Chronic Heel Pain Arising from Plantar Fasciitis
K142042 Zerona (SHL) – Non-Invasive Body Contouring of the Waist, Hips and Upper Abdomen for BMI 30-40
K143007 Zerona-Z6 OTC – Non-Invasive Dermatological Aesthetic Treatment for the Reduction of the Circumference of the Hips, Waist and Thighs
K150446 Zerona-Z6 OTC – 1X Week Protocol 6 Weeks Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist, Thighs and Upper Abdomen
a. while using the red diode, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin
b.and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
K153164 LunulaLaser the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
K162578 Zerona-Z6 OTC Non-invasive dermatological aesthetic treatment for the reduction of body circumference.