Fundamentals of Indiana LLC

Venus Bliss™ is cleared by the FDA and licensed by Health Canada for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less, with the diode laser applicators. The (MP)² applicator is cleared by the FDA for temporary reduction in the appearance of cellulite, and licensed by Health Canada for temporary increase of skin tightening, temporary circumferential reduction, and temporary cellulite reduction. Venus Bliss™ has CE Mark as a non-invasive medical aesthetic device enabling a comprehensive approach leading to body contouring, addressing fat reduction, skin tightening, circumference reduction, and cellulite reduction.

Venus Versa™ is cleared by the FDA, licensed by Health Canada, and has CE Mark as a multi-application device intended to be used in aesthetic and cosmetic procedures. The SR515 and SR580 applicators are cleared by the FDA, licensed by Health Canada, and have CE Mark for the treatment of benign pigmented epidermal and cutaneous lesions and treatment of benign cutaneous vascular lesions. The HR650/HR650XL and HR690/HR690XL applicators are cleared by the FDA, licensed by Health Canada, and have CE Mark for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for Fitzpatrick skin types I-IV. The AC Dual applicator is cleared by the FDA, licensed by Health Canada, and has CE Mark for the treatment of acne vulgaris. The DiamondPolar™ and OctiPolar™ applicators on the Venus Versa™ system are cleared by the FDA for non-invasive treatment of moderate to severe facial wrinkles and rhytides on females with Fitzpatrick skin types I-IV. The DiamondPolar™ applicator is licensed by Health Canada and has CE Mark for non-invasive treatment of moderate to severe facial wrinkles and rhytides on females with Fitzpatrick skin types I-IV. The OctiPolar™ applicator on the Venus Versa™ system is licensed by Health Canada and has CE Mark for temporary body contouring via skin tightening, circumferential reduction, and cellulite reduction. The NanoFractional RF™ (Viva) applicator is cleared by the FDA, licensed by Health Canada, and has CE Mark for dermatological procedures requiring ablation and resurfacing of the skin.

NeoGraft^® is cleared by the FDA, licensed by Health Canada and has CE Mark with indication for use in suction-assisted follicular extraction and re-implantation. It is an auto-graft system and can be used on both male and female patients.

ARTAS iX™ is cleared by the FDA, licensed by Health Canada and has CE Mark with indication for use for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. ARTAS iX™ is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation; creating recipient sites; and implanting harvested hair follicles.

Venus Legacy™ is cleared by the FDA for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in females with Fitzpatrick skin types I-IV with the OctiPolar™ and DiamondPolar™ applicators, and temporary reduction in the appearance of cellulite with the 4D Body (LB2) and 4D Face (LF2) applicators. It is licensed by Health Canada and has CE Mark for the temporary increase of skin tightening, temporary circumferential reduction, temporary cellulite reduction, and temporary wrinkle reduction.

Venus Velocity™ is cleared by the FDA, licensed by Health Canada and has CE Mark for hair removal, permanent hair reduction (defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen), and the treatment of pseudofolliculitis barbae for all Fitzpatrick skin types.

Venus Fiore™ received regulatory approval in Israel for aesthetic and functional treatment of the vagina, labia and mons pubis. Venus Fiore™ is available for sale in India, Hong Kong, and other selected Asian countries.

Venus Viva™ is cleared by the FDA, licensed by Health Canada, and has CE Mark for dermatological procedures requiring ablation and resurfacing of the skin. The DiamondPolar™ applicator is cleared by the FDA, licensed by Health Canada and has CE Mark for the treatment of moderate to severe wrinkles and rhytides in Fitzpatrick skin types I-IV.

Venus Freeze Plus™ is cleared by the FDA for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in females with Fitzpatrick skin types I-IV. It is licensed by Health Canada for temporary skin tightening, and temporary reduction in the appearance of cellulite on the abdomen and flanks, using the DiamondPolar™ and OctiPolar™ applicators. The DiamondPolar™ applicator on Venus Freeze Plus™ has CE Mark for the non-invasive treatment of moderate to severe facial wrinkles and rhytides, and the increase of skin tightening, temporary circumferential reduction, and cellulite reduction with the OctiPolar™ applicator.

Venus Heal™ is licensed by Health Canada and can be used for the treatment of both acute and chronic disorders of the musculoskeletal system, such as muscle spasms, back pain, and soft tissue injuries, and results in effects such as pain relief, myorelaxation, increase of local blood circulation, and edema reduction. In the U.S., Venus Heal™ is cleared by the FDA for the relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. These indications enable the treatment of certain soft tissue injuries and conditions.

Venus Glow™ is cleared by the FDA as a Class I motorized dermabrasion device. It provides a dermal rejuvenation treatment that works to open up and deep-clean pores. Venus Concept is the exclusive distributor for Venus Glow™.

Venus Epileve™ is licensed by Health Canada and has CE Mark for hair removal, permanent hair reduction (defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen), and the treatment of pseudofolliculitis barbae for all Fitzpatrick skin types. Venus Epileve™ is also CE-Marked for hirsutism.

Venus Freeze™ is cleared by the FDA for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in females with Fitzpatrick skin types I-IV. It is licensed by Health Canada for temporary skin tightening, and temporary reduction in the appearance of cellulite on the abdomen and flanks, using the DiamondPolar™ and OctiPolar™ applicators. The DiamondPolar™ applicator on Venus Freeze™ has CE Mark for the non-invasive treatment of moderate to severe facial wrinkles and rhytides, and the increase of skin tightening, temporary circumferential reduction, and cellulite reduction with the OctiPolar™ applicator.

Venus Swan™ is cleared by the FDA for the non-invasive treatment of moderate to severe facial wrinkles and rhytides, and licensed by Health Canada for the non-invasive treatment of cellulite reduction, skin tightening, and temporary reduction in the appearance of stretch marks.