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Waterlase iPlus with the fractional handpiece is indicated for use in dermatology for skin resurfacing. Waterlase iPlus when used with the non-fractional handpieces is indicated for use in the following oral hard and soft tissue dental applications: Waterlase laser removal of porcelain and ceramic crowns and veneers General Hard Tissue Indications (for use on adult and pediatric patients) - Class I, II, III, IV and V cavity preparation - Caries removal - Hard tissue surface roughening or etching - Enameloplasty, excavation of pits and fissures for placement of sealants Root Canal Hard Tissue Indications - Tooth preparation to obtain access to root canal - Root canal preparation including enlargement - Root canal debridement and cleaning Root Canal Disinfection - Laser root canal disinfection after endodontic treatment Endodontic Surgery (Root Amputation) Indications - 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) - Apicoectomy amputation of the root end - Root end preparation for retrofill amalgam or composite - Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Bone Surgical Indications - Cutting, shaving, contouring and resection of oral osseous tissues (bone) - Osteotomy Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient) Incision, excision, vaporization, ablation and coagulation of oral soft tissues including: - Excisional and incisional biopsies - Exposure of unerupted teeth - Fibroma removal - Flap preparation incision of soft tissue to prepare a flap and expose the bone - 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 - Gingival incision and excision - Hemostasis - Implant recovery - Incision and drainage of abscesses - Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery - Leukoplakia - Operculectomy - Oral papillectomies - Pulpotomy - Pulp extirpation - Pulpotomy as an adjunct to root canal therapy - Root canal debridement and cleaning - Reduction of gingival hypertrophy - Soft tissue crown lengthening - Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - Vestibuloplasty - Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Laser Periodontal Procedures - Full thickness flap - Partial thickness flap - Split thickness flap - Laser soft tissue curettage - 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 - Removal of granulation tissue from bony defects - Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility) - Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours) - Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.) - Osseous crown lengthening - Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage - Waterlase Er.Cr: Y SGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.

Waterlase iPlus utilizes an Er, Cr YSGG (2780nm) solid-state laser and water atomization technology for hard and soft tissue incision, excision, ablation, vaporization and coagulation of soft and hard tissue. The laser consists of a console the houses the laser head, power supply, cooling system, micro-processor and electronics, a footswitch which activates the laser, and a fiber optic cable for delivery of laser energy through a handpiece to the treatment site. A fine water spray is also emitted from the handpiece to cool and hydrate the issue. The laser is controlled through a touch screen display which serves as the User Interface.

1. Dental Soft Tissue Indications Incision, excision, vaporization, ablation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: - · Excisional and incisional biopsies - · Exposure of unerupted teeth - · Fibroma removal - · Frenectomy - · Frenotomy - · Gingival troughing for crown impressions - · Gingivectomy - · Gingivoplasty - · Gingival incision and excision - · Hemostasis and coagulation - · Implant recovery - · Incision and drainage of abscess - · Leukoplakia - · Operculectomy - · Oral papillectomies - · Pulpotomy - · Pulpotomy as an adjunct to root canal therapy - · Reduction of gingival hypertrophy - · Soft-tissue crown lengthening - · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - · Vestibuloplasty - · Tissue retraction for impression - 2. Laser Periodontal Procedures - · Laser soft-tissue curettage - · Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket · Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility) - 3. Whitening - · Light activation for bleaching materials for teeth whitening - · Laser-assisted whitening/bleaching of teeth - 4. Pain Therapy · Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain. The Epic 980 uses an Indium Gallium Arsenide (InGaAs) solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site. A visible light is emitted at the same time to visually identify the treatment location. The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications.

Waterlase Laser System Family is intended for use in oral hard and soft tissue dental applications. The Indications for Use are as follows: Waterlase laser removal of porcelain and ceramic crowns and veneers General Hard Tissue Indications (for use on adult and pediatric patients) - Class I, II, III, IV and V cavity preparation - . Caries removal - Hard tissue surface roughening or etching ● - Enameloplasty, excavation of pits and fissures for placement of sealants ● Root Canal Hard Tissue Indications - Tooth preparation to obtain access to root canal - Root canal preparation including enlargement ● - Root canal debridement and cleaning ● Root Canal Disinfection - Laser root canal disinfection after endodontic treatment Endodontic Surgery (Root Amputation) Indications - 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) - Apicoectomy - amputation of the root end - Root end preparation for retrofill amalgam or composite ● - Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic ● tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Bone Surgical Indications - . Cutting, shaving, contouring and resection of oral osseous tissues (bone) - Osteotomy Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient) Incision, excision, vaporization, ablation and coagulation of oral soft tissues including: - Excisional and incisional biopsies - Exposure of unerupted teeth ● - Fibroma removal ● - Flap preparation incision of soft tissue to prepare a flap and expose the bone ● - 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 - Gingivoplastv . - Gingival incision and excision ● - Hemostasis ● - Implant recovery - Incision and drainage of abscesses - Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area ● during apical surgery - Leukoplakia - Operculectomy - Oral papillectomies ● - Pulpotomy - Pulp extirpation - Pulpotomy as an adjunct to root canal therapy - Root canal debridement and cleaning - Reduction of gingival hypertrophy - Soft tissue crown lengthening - Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - Vestibuloplasty - Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic . tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Laser Periodontal Procedures - Full thickness flap ● - Partial thickness flap ● - Split thickness flap - Laser soft tissue curettage - 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 - Removal of granulation tissue from bony defects - Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue ● in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) - Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours) - Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.) - Osseous crown lengthening - Removal of subgingival calculi in periodontal pockets with periodontitis by closed ● or open curettage - Waterlase Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.

Waterlase Laser System Family utilizes an Er, Cr:YSGG (2780mm) solid-state laser and water atomization technology to safely and effectively cut, shave, contour, roughen, etch and resect oral hard-tissue and direct laser energy to perform oral soft tissue removal, incision, excision, ablation and coagulation. It is also used for specific endodontic and periodontal applications. A single laser console houses the laser head, power supply, cooling system, micro-processor. The laser is controlled through a display which serves as the User Interface. A flexible fiber optic cable, connected to the laser, delivers laser energy to the treatment site through a laser tip attached to a handpiece. A visible light emitted from the handpiece head illuminates the area. A fine water spray is also emitted from the handpiece head to cool and hydrate the issue. A variety of laser tips are available for different clinical applications. The laser is activated by a footswitch.

The Waterlase Express indications for use are as follows: General Hard Tissue Indications (for use on adult and pediatric patients) - · Class I, II, III, IV and V cavity preparation - · Caries removal - · Hard tissue surface roughening or etching - · Enameloplasty, excavation of pits and fissures for placement of sealants Root Canal Hard Tissue Indications - · Tooth preparation to obtain access to root canal - · Root canal preparation including enlargement - · Root canal debridement and cleaning Root Canal Disinfection - · Laser root canal disinfection after endodontic treatment Endodontic Surgery (Root Amputation) Indications - · 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) - Apicoectomy amputation of the root end - · Root end preparation for retrofill amalgam or composite - · Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Bone Surgical Indications - · Cutting, shaving, contouring and resection of oral osseous tissues (bone) - · Osteotomy Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient) Incision, vaporization, ablation and coagulation of oral soft tissues including: - · Excisional and incisional biopsies - · Exposure of unerupted teeth - · Fibroma removal - · Flap preparation incision of soft tissue to prepare a flap and expose the bone - · 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 - · Gingival incision and excision - · Hemostasis - Implant recovery - · Incision and drainage of abscesses - · Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery - · Leukoplakia - · Operculectomy - · Oral papillectomies - Pulpotomy - · Pulp extirpation - Pulpotomy as an adjunct to root canal therapy - · Root canal debridement and cleaning - · Reduction of gingival hypertrophy - · Soft tissue crown lengthening - · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - · Vestibuloplasty - · Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Laser Periodontal Procedures - · Full thickness flap - · Partial thickness flap - · Split thickness flap - · Laser soft tissue curettage - · 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 - · Removal of granulation tissue from bony defects - · Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) - · Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours) - Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.) - · Osseous crown lengthening - · Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage - · Waterlase Er.Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.

Waterlase Express is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr.YSGG) solid-state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2780 nm. The laser system consists of a top-table console which houses the laser head, power supply, cooling system, micro-processor and a removable tablet PC as a control panel. A flexible fiber cable, connected to the laser console, delivers laser energy to the treatment site through a laser tip attached to a Handpiece. A visible light emitted from the Handpiece head illuminates the area. The laser is activated by means of a wireless footswitch. Various laser tips are available for different clinical applications. Waterlase Express utilizes advanced laser and water atomization technologies to cut. shave, contour, roughen, etch and resect oral hard tissues, and direct laser energy, with or without water for cooling and hydration, to perform oral soft tissue removal, incision, excision, ablation and coagulation as well as specific endodontic and periodontal applications.

The Waterlase iPlus S is intended for use as a laser surgical instrument in the following medical specialties requiring the incision, excision, vaporization, ablation and coagulation of soft tissue: Dermatology/Plastic Surgery, Ear, Nose and Throat (ENT), Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/Maxillofacial Surgery, Podiatry, Pulmonary Surgery and Thoracic Surgery. It is indicated for the following expanded Indications for Use: Dermatology/Plastic Surgery: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking of benign tumors, decubitis ulcers, cysts, diagnostic biopsy and skin resurfacing and treatment of wrinkles. Ear, Nose and Throat (ENT): The following indications can be used with the Angled or Straight Handpieces: ENT surgery in soft, mucosal, cartilaginous and bony tissue, including endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomy) dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangiectasias, septoplasty, lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia. Gastroenterology: The following indications can be used with the Angled or Straight Handpieces: Gastroenterologic surgery of soft tissue, including cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias and telangiectasias of the Osler-Weber-Rendu disease. General Surgery: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated. Genitourinary/Urology: The following indications are used with the Angled Handpieces: Genitourinary surgery of soft tissue, including treatment of bladder, urethral and ureteral tumors, superficial urinary bladder tumors, invasive bladder carcinomas, urethral and penile hemangioma, urethral strictures, lesions of the external genitalia, urethra and anus, penis, scrotum, (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon, bladder neck obstructions. The following indications are used with the Straight Handpieces: Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy. Gynecology: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. Ophthalmology: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: General ophthalmic soft tissue surgical indications such as: Incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit. Oral/Maxillofacial Surgery: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Oral/dental procedures for incision, excision, ablation, vaporization and hemostasis of soft tissue during gingivoplasties, gingivectomies, frenectomies, benign and malignant lesion removal, biopsies, leukoplakia and fibrotomy. Podiatry: The following indications can be used with the Angled or Contra-Angled Handpieces: Warts, plantar verrucae, large mosaic verrucae and matrixectomy. Pulmonary Surgery: The following indications can be used with the Angled or Straight Handpieces: Open and endoscopic pulmonary surgery. Thoracic Surgery: The following indications can be used with the Angled or Straight Handpieces: Surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery.

The Waterlase iPlus S system is an erbium, chromium, yttrium, scandium, garnet (ER,CR:YSGG) solid state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2.78 µm (2780 nm). The laser consists of a cabinet which houses the power supply, the cooling system, micro-controller, laser, foot switch, and fiber optic for delivery of laser energy with the fiber optic handpiece. Various handpiece and tip types are available depending upon the clinician's preference for the different applications. The Waterlase iPlus S system utilizes direct laser energy either with or without water for cooling and hydration to perform soft tissue incision, resection, ablation, vaporization, coagulation and hemostasis.

The Epic 10 is intended for use as a laser surgical instrument requiring the incision, excision, vaporization, ablation and hemostasis, or coagulation of soft tissue. It is indicated for the following expanded Indications for Use: General Surgery, Dermatology, Plastic Surgery and Podiatry - Debridement of wounds.

The EPIC 10 system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC 10 laser is comprised of a base console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The Epic 10 delivery system consists of the following: Fiber Optic Assembly, Surgical Handpiece, and Single-use tips.