# K171443: Etherea MX

- Pathway: 510(k) (Traditional)
- Applicant: Vydence Medical Industria E Comercio Ltda
- Decided: Apr 20, 2018 after 339 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
IPL 540nm-1200nm Filter * benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), * lentigines, nevi, and cafe-au-lait macules; * the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * The treatment of benign cutaneous lesions including warts, scars and striae. * The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair growth is defined as the long-term , stable reduction in the number of hairs regrowing when measured at 6,9 and 12 months after the completion of a treatment regime. * Use on all skin types (Fitzpatrick I-VI). IPL 580nm-1200nm Filter * The treatment of moderate inflammatory acne vulgaris. * The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). * The treatment of face and body vascular and benign pigmented lesions. * The treatment of benign cutaneous lesions, including scars and striae. * The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * The removal of unwanted hair to effect stable long-term or permanent hair reduction. . Permanent reduction in hair growth is defined as the long-term , stable reduction in the number of hairs regrowing when measured at 6,9 an 12 months after the completion of a treatment regime. Intense IR Handpiece » intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature. It’s also indicated for the treatment in the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain. 1064 LongPulse Handpiece * removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-V1, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime; * Treatment of pseudofolliculitis barbae (PFB) * Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas 1064 LongPulse Handpiece Short Pulse Operation » intended for the coagulation and hemostasis of benign vascular lesions such as but not limited to, rosacea/ diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloidscars), and warts. * is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. * For use on all skin types(Fitzpatrick I-VI), including tanned skin. 1064 Handpiece - Onychomycosis * podiatry (i.e. ablation, vaporization, incision, excision, and coagulation of soft tissue) including matrixectomy, radical nail excision, periungual and subungual warts, plantar warts, neuromas, * temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.). Acroma QS handpiece The 1064 nm wavelength is indicated for: * treatment of benign vascular lesions such as (but not limited to): port wine stains; hemangiomas; warts; superficial and deep telangiectasias (venulectasias); reticular veins (0.1-4.0 mm diameter) of the leg; rosacea; venous lakes; leg veins; spider veins; Poikiloderma of Civatte; angiomas; * benign cutaneous lesions, such as, but not limited to: warts; scars; striae; psoriasis; * benign pigmented lesions such as, but not limited to: lentigos (age spots); solar lentigos (sun spots); cafe-au-lait macules; seborrheic keratoses; nevi and Nevus of Ota; chloasma; verrucae; skin tags; keratoses; the removal of black, blue or green tattoos (significant reduction in the intensity of black and/or blue/black tattoos); plaques; * pigmented benign lesions to reduce lesions’ size for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. * the non-ablative treatment of facial wrinkles, including but not limited to: periocular wrinkles; perioral wrinkles; » laser skin resurfacing procedures for the treatment of acne scars; wrinkles, » reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. » indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. Acroma QS handpiece (continued) The 532 nm wavelength is indicated for: * incision, excision, ablation, vaporization of soft tissue; * tattoo removal: light blue, yellow, red; green; * benignvascular lesions: Hemangiomas (port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); angiomas (cherry, spider); telangiectasias; spider nevi; * benign pigmented lesions: cafe-au-lait macules; lentigines (senile and solar); freckles (ephelides); chloasma; nevi; nevus spillus; Nevus of Ota; Becker's Nevi; * other benign pigmented cutaneous lesions: verrucae; skin tags; keratoses; plaques 1540 GoSmooth Handpiece * The 1540 Fractional Non-ablative Laser Handpiece is intended for use in the coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars. 2940 DualMode Handpiece - non-fractional * DERMATOLOGY AND PLASTIC SURGERY Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars); Debulking benign tumors; Debulking cysts; Superficial skin lesions; : Diagnostic biopsies; Decubitus ulcers;

Source page: https://510kreport.com/device/K171443
Methodology: https://510kreport.com/methodology