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With handheld applicators: PMS mode: Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance. Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation. TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. With Chair Back applicator: TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal household work activities.

StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the handheld applicators and in the back of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current. This current stimulates neurons and activates muscle contractions. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply, handheld applicators and a chair.

Er: YAG laser (2940 nm wavelength) in dentistry: - · Intra-oral soft tissue surgery (incision, excision, ablation, coagulation); - · Leukoplakia; - · Pulpotomy as adjunct to root canal retreatment; - · Pulp extirpation: - Removal of fibromae; - · Removal of granulated tissue; - · Caries removal, cavity preparation, enamel roughening; - Sulcular debridement; - · Tooth preparation to obtain access to root canal debridement and cleaning, root canal preparation including enlargement; - · Cutting, shaving, contouring and resection of oral osseous tissue (bone); - · Osteotomy, osseous crown lengthening, osteoplasty; - · Apicectomy surgery; - · Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage; - · Laser removal of porcelain and ceramic crowns and veneers; - · Flap preparation incision of soft-tissue to prepare a flap and expose the bone; - · Cutting bone to prepare a window access to the apex (apices) of the root(s); - · Root-end preparation for retrofill amalgam or composite; - · Full thickness flap; - · Partial thickness flap; - · Split thickness flap; - · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; - · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket Iming junctional epithelium: - · Excisional and incisional biopsies; - · Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions); - · Frenectomy and frenotomy; - · Gingival troughing for crown impressions; - · Gingivectomy; - · Gingivoplasty: - · Implant recovery; - · Root canal debridement and cleaning; - · Soft tissue crown lengthening; - · Laser root canal disinfection after endodontic treatment; Er: Y AG laser (2940 nm wavelength) in dermatology and other surgical areas: The LightWalker Er: YAG laser is intended for surgical incision, cutting, ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. · Dermatology and Plastic Surgery Indications: epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing; · ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; · Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy; - Uvulopalatoplasty by laser resurfacing · General Surgery Indications: Surgical incision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation; - · Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; - · Ophtalmology Indications: Soft tissue surrounding the eye; · Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma; · Genitourinary Indications: Lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon; - · Dermatological procedures requiring resurfacing of soft tissue with Fotona FS-01 fractionated handpiece. Nd:YAG laser (1064 nm wavelength) in dentistry: - · Excisional and incisional biopsies; - · Excision and vaporization of herpes simplex I and II; - · Exposure of unerupted teeth; - · Fibroma removal; - Frenectomy and frenotomy; - · Gingival troughing for crown impressions; - · Gingivectomy; - · Gingivoplasty; - · Gingival incision and excision; - · Hemostasis; - Implant recovery; - · Incision and drainage of abscess; - · Laser assisted uvulopaletoplasty (LAUP); - · Operculectomy; - · Oral papillectomies; - · Pulpotomy and pulpotomy as an adjunct to root canal therapy; - · Reduction of denture hyperplasia; - · Reduction of gingival hypertrophy; - · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy; - · Removal of post-surgical granulations; - · Soft tissue crown lengthening; · Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and toothmobility); - · Tissue retraction for impression; - Treatment of aphtous ulcers; - · Vestibuloplasty; · Laser assisted new attachment procedure (cementum-mediated periodontal ligament no the root surface in the absence of long junctional epithelium); · Periodontal regeneration - true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface. Nd:YAG laser (1064 nm wavelength) in dermatology and other surgical areas: · 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-VI, including tanned skin*; · Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins; · Treatment of wrinkles; · Treatment of mild to moderate inflammatory acne vulgaris; · General surgery indications: surgical incision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal; · Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas; · Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.); · Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicosities. Nd:YAG laser (1064 nm wavelength) therapy: · Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.

The Fotona LightWalker Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er:YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.

Fotona StarFormer is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.

StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the seat of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current which causes muscle contraction in the entire pelvic floor area, increasing the strength and endurance of the pelvic floor. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply and a chair.

Fotona StarFormer is intended to be used under medical supervision for therapy for the treatment of medical diseases and conditions. Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. -Relaxation of muscle spasm, -Prevention or retardation of disuse atrophy, -Increasing local blood circulation, -Muscle re-education, -Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, -Maintaining or increasing range of motion. Fotona StarFormer is indicated for improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen -Strengthening, Toning and Firming of buttocks and thighs

StarFormer is a non-invasive therapeutic device. The device comprises a magnetic stimulation coil located in the applicator which is placed over the treatment area. During the treatment, an alternating electric current is sent into the stimulation coil. The alternations in the electric current produce electromagnetic field that interacts with the tissues of the human body. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply and an applicator with electromagnetic coil.

The AvalancheLase Family and its accessories will be marketed for the following indications for use: Alexandrite laser (755 nm wavelength): Indications in Dermatology and Aesthetics - Temporary hair reduction. - Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment hair reduction 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. On all skin types (Fitzpatrick I- VI) including tanned skin. - Treatment of benign pigmented lesions. - Treatment of wrinkles - The photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). Nd:YAG laser (1064 nm wavelength): The Nd:YAG laser module is intended for incision, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI. Indications in Dermatology and Aesthetics: - 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-VI, including tanned thair 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 treament regime. - Treatment of wrinkles. - Treatment of wrinkles with S11 (LX Runner) scanner. - Treatment of mild to moderate inflammatory acne vulgaris. - Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, - hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins. - Podiatry (ablation, vaporization, incision, 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 Trichophylla rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) NNd:YAG laser (1064 nm wavelength) therapy: - Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.

The AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamppumped laser sources in one housing, with optical cavities containing the Nd:YAG and Alexandrite crystals. A green diode aiming beam (520 mm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical manual handpiece or scanner. The AvalancheLase Family is designed to operate in single wavelength (Nd:YAG or Alexandrite) configurations (models) and dual wavelength (Nd: YAG and Alexandrite) configurations (models).

1064 nm Diode Laser in dentistry: - · Excisional and incisional biopsies - · Excision and vaporization of herpes simplex I and II - · Frenectomy and frenotomy - · Gingivectomy - Gingivoplasty - · Gingival incision and excision - · Hemostasis - · Implant recovery - · Operculectomy - Pulpotomy and pulpotomy as an adjunct to root canal therapy - · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy - · Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility) - · Treatment of aphthous ulcers and herpetic lesions 1064 nm Diode Laser in dermatology and other surgical areas: · General surgery indications: surgical incision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, menibrane, lymph vessels and nodes, organs and glands, fibroma removal. • Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas. · Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.) 1064 nm Diode Laser in therapy: · Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle. 810 nm Diode Laser in dentistry: · Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology - · Oral/Maxillofacial Indications: Incision, excision, vaporization, ablation and/or coagulation of soft tissue - · Gingival troughing for crown impression - · Gingivectomy - Gingivoplasty - 。 Gingival incision and excision - 。 Hemostasis and coagulation - · Excisional and incisional biopsies - Fibroma removal - 。 Frenectomy and frenotomy - 。 Oral papillectomies - · Soft tissue crown lengthening - 。 Treatment of aphthous ulcers - 。 Treatment of herpetic lesions - · Periodontology: - · Laser soft tissue curettage - · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket - Cosmetic Dentistry: - 。 Laser-assisted bleaching/whitening of the teeth - · Light activation for bleaching materials for teeth whitening - Implant recovery 810 nm Diode Laser in therapy: · Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle. 980 nm Diode Laser in dentistry: · Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology and thoracic surgery - Gingival troughing - Crown lengthening - Gingivoplasty • - · Coagulation - Implant uncovery - Implant recovery - Soft tissue curettage - Sulcular debridement - · Biopsy - · Frenectomy - Hemostasis of donor site - Operculectomy - Exposure of unerupted teeth . - Pulpotomy . - Treatment of aphthous ulcers . - Excision of lesions · - Light activation of bleaching materials for teeth whitening •

The Fotona XPulse Laser System Family is a multi-application, multi-technology laser system family that supports the diode laser technology. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The Fotona XPulse Laser System Family consists of a console and a footswitch. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The following wavelengths are currently available with the XPulse System Family: 810 nm, 980 nm and 1064 nm. The following handpieces are to be used with Fotona XPulse Laser System Family: R21 (variants C2, C3, SHP and EHP), R26 (variants: black, green, blue, silver and red), Genova- and MarcCo (variants S, M and L).

The Dynamis Pro Family and its accessories will have the same intended use as predicate device and will be marketed for the following indications for use: Er: YAG laser (2940 nm wavelength): The Dynamis Er:YAG laser is intended for surgical incision/excision, cutting ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. - Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing; - Soft tissue resurfacing with S22 and S22-T scanner; - ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; - Oral/Maxillofacial Indications: Oral and glossal lesions; - Uvulopalatoplasty by laser resurfacing - Ophtalmology Indications: Soft tissue surrounding the eye; - Intra-oral soft tissue incision, excision, ablation, coagulation - General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation is necessary: - Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma; - Genitourinary Indications: lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon; - Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; - The Fotona F-22 Handpiece is intended for: - In fractionated mode: Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; - In non-fractionated mode: - General Surgery Indications: - Surgical incision/excision. vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation is necessary; - The Fotona FS-01 and X-Restart Handpieces are intended for: - Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; Nd:YAG laser (1064 nm wavelength): The Dynamis Nd:YAG laser is intended for incision, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI. - Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy; - Treatment of Aphthous Ulcers; - Excision and Vaporization of Herpex Simplex I and II; - Laser assisted uvulopalatoplasty (LAUP); - Laser assisted lipolysis; - 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-VI, 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 treament regime; - Treatment of wrinkles; - Treatment of wrinkles with S11 scanner; - Treatment of mild to moderate inflammatory acne vulgaris; - Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins; - Podiatry (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 T. mentagrophytes, and/or yeasts Candida albicans, etc.) - Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities. Nd:YAG laser (1064 nm wavelength) therapy: - Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.

The Dynamis Pro Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamppumped laser sources in one housing, with optical cavities containing the Er: Y AG and Nd: Y AG crystals. A red diode aiming beam (650 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner handpiece (in the case of the Er:YAG laser), or through an optical fiber delivery system to an optical manual or scanner handpiece (in the case of the Nd:YAG laser). Optionally, the Nd:YAG therapeutic and aiming laser beams can be guided through a fiber having a connector on the proximal end and a bare fiber on the distal end. The Dynamis Pro Family is designed to operate in single wavelength (Nd: YAG or Er.Y AG) configurations (models) and dual wavelength (Nd: Y AG and Er: Y AG) configurations (models).

810 nm Diode Laser System: - · Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: - 。 Gingival troughing for crown impression - · Gingivectomy - · Gingivoplasty - 。 Gingival incision and excision - 。 Hemostasis and coagulation - · Excisional and incisional biopsies - Fibroma removal - · Frenectomy and frenotomy - · Oral papillectomies - · Soft tissue crown lengthening - 。 Treatment of aphthous ulcers - · Treatment of herpetic lesions - · Periodontology: - · Laser soft tissue curettage. - · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket - Cosmetic Dentistry: - · Laser-assisted bleaching/whitening of the teeth, - · Light activation for bleaching materials for teeth whitening - · Implant recovery - · Surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology 810 nm Diode Laser Module: · Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: - 。 Gingival troughing for crown impression - · Gingivoplasty - · Soft tissue crown lengthening - 。 Treatment of aphthous ulcers - 。 Treatment of herpetic lesions 810 nm Diode Laser System & Module in therapy: · Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle. 980 nm Diode Laser: - · Gingival troughing - · Crown lengthening - · Gingivoplasty - · Coagulation - Hemostasis of donor site - Implant recovery - Implant uncovery - · Soft tissue curettage - · Sulcular debridement - Biopsy - · Frenectomy - Operculectomy - Exposure of unerupted teeth - Pulpotomy - Treatment of aphthous ulcers - · Excision of lesions - · Light activation of bleaching materials for teeth whitening · Surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, and thoracic surgery. 445 nm Diode Laser: · Incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue

The Fotona XPulse Pro Laser Platform is a multi-application, multi-technology platform that supports the diode laser technology. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The Fotona XPulse Pro Laser Platform consists of a console, a footswitch and attachable laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The following wavelengths are currently available with the XPulse platform: 445 nm, 810 mm and 980 nm. Following handpieces are to be used with Fotona Xpulse Pro Laser Platform: R21-SHP, R26 (variants: black, green, blue, silver and red), R24, R30, Genova and MarcCo (variants S, M & L).

Er: Y A G laser (2940 nm wavelength) in dentistry: - · Intra-oral soft tissue surgery (incision, excision, ablation, coagulation); - · Leukoplakia; - · Pulpotomy as adjunct to root canal retreatment; - · Pulp extirpation; - Removal of fibromae: - · Removal of granulated tissue; - · Caries removal, cavity preparation, enamel roughening; - · Sulcular debridement: - · Tooth preparation to obtain access to root canal debridement and cleaning, root canal preparation including enlargement: - · Cutting, shaving, contouring and resection of oral osseous tissue (bone); - · Osteotomy, osseous crown lengthening, osteoplasty; - · Apicectomy surgery: - · Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage; - · Laser removal of porcelain and ceramic crowns and veneers; - · Flap preparation incision of soft-tissue to prepare a flap and expose the bone; - · Cutting bone to prepare a window access to the apex (apices) of the root(s); - · Root-end preparation for retrofill amalgam or composite; - · Full thickness flap; - · Partial thickness flap: - · Split thickness flap; - · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; - · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium; · Excisional and incisional biopsies; - · Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions); - · Frenectomy and frenotomy; - · Gingival troughing for crown impressions; - · Gingivectomy: - · Gingivoplasty; - Implant recovery: - · Root canal debridement and cleaning; - · Soft tissue crown lengthening; - · Laser root canal disinfection after endodontic treatment; Er:Y AG laser (2940 nm wavelength) in dermatology and other surgical areas: The LightWalker Er: YAG laser is intended for surgical incision/excision, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. · Dermatology and Plastic Surgery Indications: epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing: · ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; - · Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy; · Uvulopalatoplasty by laser resurfacing · General Surgery Indications: Surgical incision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation; - · Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; - · Ophtalmology Indications: Soft tissue surrounding the eye; · Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma: · Genitourinary Indications: Lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, valvar lesions, polyps and familial polyps of the colon; · Dermatological procedures requiring resurfacing of soft tissue with Fotona FS-01 fractionated handpiece. Nd:YAG laser (1064 nm wavelength) in dentistry: - · Excisional and incisional biopsies; - · Excision and vaporization of herpes simplex I and II; - · Exposure of unerupted teeth; - Fibroma removal; - Frenectomy and frenotomy; - · Gingival troughing for crown impressions; - · Gingivectomy; - · Gingivoplasty; - · Gingival incision and excision; - Hemostasis; - Implant recovery: - · Incision and drainage of abscess; - · Laser assisted uvulopaletoplasty (LAUP); - · Operculectomy: - Oral papillectomies; - · Pulpotomy and pulpotomy as an adjunct to root canal therapy; - · Reduction of denture hyperplasia; - · Reduction of gingival hypertrophy; - Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy; - Removal of post-surgical granulations; - · Soft tissue crown lengthening: · Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and toothmobility): - · Tissue retraction for impression; - Treatment of aphtous ulcers: - · Vestibuloplasty; · Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium); · Periodontal regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface. Nd:YAG laser (1064 nm wavelength) in dermatology and other surgical areas: · 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-VI. including tanned skin *; · Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins; - Treatment of wrinkles: - · Treatment of mild to moderate inflammatory acne vulgaris; - · General surgery indications: surgical incision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal; · Podiatry (ablation, vaporization, incision, and coagulation of soft tissue) including. Matrixectomy, Periungual and subungual warts. Plantar warts, Radical nail excision, Neuromas; · Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.); · Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicosities. Nd:YAG laser (1064 nm wavelength) therapy: · Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle. *Note: Permanent hair reduction is defined as the long-term, stable redction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Fotona LightWalker Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er: YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The Er:YAG laser is intended to be used for incision/excision, cutting, ablation, vaporization and coagulation of soft and hard tissue in dentistry, dermatology and other surgical areas. The Nd:YAG laser is intended to be used for various intra oral treatments in dentistry, and for various surgical and aesthetic applications in dermatology and other surgical areas.

The StarWalker Laser System Family is indicated for: 1064 nm wavelength in Q-switched mode: -Removal of dark (black, blue, brown) tattoo ink -Treatment of nevus of ota -Treatment of common nevi -Removal and lightening of unwanted hair -Skin resurfacing procedures for the treatment of acne scars and wrinkles -Treatment of melasma -General dermatology indications: Incision, excision, ablation and vaporization of soft tissue 1064 nm wavelength in long pulse mode: -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-VI, including tanned skin -Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins -Coagulation and hemostasis of soft tissue -Treatment of wrinkles -Treatment of mild to moderate inflammatory acne vulgaris 1064 nm wavelength in PICO mode: -Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple -Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV -Treatment of acne scars in Fitzpatrick Skin Types II-V -Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV 532 nm wavelength in Q-switched mode (nominal delivered energy of 585 mm with the optional 585 nm and 650 nm dye converter handpieces): -Red, tan, purple and orange tattoo ink removal -Sky blue (light) tattoo ink removal -Green tattoo tattoo ink removal -Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus -Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi -Seborrheic Keratosis -Treatment of post-inflammatory hyperpigmentation -Skin resurfacing procedures for the treatment of acne scars and wrinkles -Removal of epidermal pigmented lesions 532 nm wavelength in long pulse mode: -Incision, ablation vaporization, coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. -The treatment (hemostasis, color lightening, blanching, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia) 532 nm wavelength in PICO mode: -Tattoo removal in Skin Types I - III -Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV

The Fotona StarWalker Laser System Family is based on the previously cleared Fotona StarWalker Laser System Family (K171227).The device is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd: Y AG laser is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing variable spot handpiece. Optionally, the KTP Nd:YAG beam can be guided to a 585nm dye converter handpiece, or to a 650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 nm or a 650 nm wavelength, correspondingly. The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size.