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See the attached pages 1-3 for a list of indications for use. The attached list of indications are in addition to the already cleared indications. Indications for Use: Ear, Nose and Throat and Oral Surgery Hemostasis, incision, excision, ablation ,coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include - Removal of benign lesions from the ear, nose and throat . - Excision and vaporization of vocal cord nodules and polyps . - Incision and excision of carcinoma in situ ● - Ablation and vaporization of hyperkeratosis . - Excision of carcinoma of the larynx - Laryngeal papillomectomy . - Excision and vaporization of herpes simplex I and II . - . Neck dissection Arthroscopy: Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include: - Menisectomy - Synovectomy ● - . Chondromalacia Gastroenterology Hemostasis, incision, excision,ablation,coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: - Hemostasis of upper and lower GI bleeding . - Excision and vaporization of colorectal carcinoma ● - Excision of polyps ● General Surgery, Dermatology , Plastic Surgery and Podiatry Excision ,ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin,fat or muscle tissue and dermabrasion. Examples include: - Matrixectomy - Excision of neuromas ● - Excision of periungual and subungual warts ◆ - Excision of plantar warts ● - Excision of keloids ● - Liver resection . - Excision of cutaneous lesions . - Hemorrhoidectomy . - Appendectomy . - Debridement of decubitus ulcers . - Hepatobiliary tumors . - Mastectomy . - Dermabrasion ● - Vaporization and hemostasis of capillary hemangioma ● - Excision, vaporization and hemostasis of abdominal tumors ● - Excision, vaporization and hemostasis of rectal pathology ● - . Pilonidal cystectomy - . Herniorapphy - Adhesiolysis - Parathyroidectomy ● - Laparoscopic cholecystectomy . - Thyroidectomy - Resection of organs ● - Debridement of wounds ● - Phototcoagulation of teleangectasia of the legs and face ● - Photocoagulation of vascular lesions of the face and extremities . Urology Excision, vaporization, incision,coagulation,ablation and hemostasis of urological tissues. Examples include: - Vaporization of urethral tumors - Release of urethral stricture . - Removal of bladder neck obstruction . - Excision and vaporization of condyloma ● - Lesions of external genitalia . Gynecology Ablation, excision,incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: - Endometrial ablation ● - Excision or vaporization of condylomata acuminata ◆ - Vaporization of cervical intraepithelial neoplasia ● - Cervical conization . - Menorrhagia . Neurosurgery Vaporization, coagulation,excision, incision, ablation and hemostasis of soft tissue. Example includes: - Hemostasis in conjunction with menigiomas . Ophthalmology Retinal photocogulation Diabetic retinopathy Pulmonary Surgery Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include: - Tracheobronchial malignancy or stricture . - Benign and malignant pulmonary obstruction ● - Endoscopic pulmonary applications .

The Cerals D10 Diode Laser operates with a power range of 1-10W in the CW or pulsed mode. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end.

See the attached pages 1-3 for a list of indications for use. The attached list of indications is in addition to the already cleared indications. Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation ,coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include: Removal of benign lesions from the ear, nose and throat; Excision and vaporization of vocal cord nodules and polyps; Incision and excision of carcinoma in situ; Ablation and vaporization of hyperkeratosis; Excision of carcinoma of the larynx; Laryngeal papillomectomy; Excision and vaporization of herpes simplex I and II; Neck dissection. Arthroscopy: Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include: Menisectomy; Synovectomy; Chondromalacia. Gastroenterology: Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: Hemostasis of upper and lower GI bleeding; Excision and vaporization of colorectal carcinoma; Excision of polyps. General Surgery, Dermatology, Plastic Surgery and Podiatry: Excision ,ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin,fat or muscle tissue and dermabrasion. Examples include: Matrixectomy; Excision of neuromas; Excision of periungual and subungual warts; Excision of plantar warts; Excision of keloids; Liver resection; Excision of cutaneous lesions; Hemorrhoidectomy; Appendectomy; Debridement of decubitus ulcers; Hepatobiliary tumors; Mastectomy; Dermabrasion; Vaporization and hemostasis of capillary hemangioma; Excision, vaporization and hemostasis of abdominal tumors; Excision, vaporization and hemostasis of rectal pathology; Pilonidal cystectomy; Herniorapphy; Adhesiolysis; Parathyroidectomy; Laparoscopic cholecystectomy; Thyroidectomy; Resection of organs; Debridement of wounds; Phototcoagulation of teleangectasia of the legs and face; Photocoagulation of vascular lesions of the face and extremities. Urology: Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include: Vaporization of urethral tumors; Release of urethral stricture; Removal of bladder neck obstruction; Excision and vaporization of condyloma; Lesions of external genitalia. Gynecology: Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: Endometrial ablation; Excision or vaporization of condylomata acuminata; Vaporization of cervical intraepithelial neoplasia; Cervical conization; Menorrhagia. Neurosurgery: Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Example includes: Hemostasis in conjunction with menigiomas. Pulmonary Surgery: Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include: Tracheobronchial malignancy or stricture; Benign and malignant pulmonary obstruction; Endoscopic pulmonary applications.

The Cerals D Diode Laser operates with a power range of 1-50W in the CW or pulsed mode. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end. There is no difference between the laser that is subject of this 510(k) and the previously cleared Ceralas D Diode laser.

Intended for light activation of bleaching materials for teeth whitening. Note: This is an additional indication to the already cleared indications for use.

The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System, which has already been cleared by FDA. The cleared Ceralas D Laser System is a complete self-contained compact surgical laser that utilizes gallium aluminum arsenide (GaALAs) semiconductor diodes to generate near-infrared laser radiation. The laser employs a modular design comprised of: (1) a laser diode: (2) a cooling module containing the laser diode, thermoelectric coolers, heat sink fins and fans; (3) an optics module containing a beamsplitter for control of optical power; (4) front control and display panel; and (5) RFIshielded, transformer power supply and control electronics. Interchangeable fiber optic delivery systems are coupled to the laser via an SMA 905 connector to deliver laser radiation to the target tissues. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The wavelength for the Ceralas D Laser System is 980 ± 30nm, and its laser aiming beam wavelength is 635mm+10mm. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath.

The Ceralas D10 Laser System that is the subject of this 510(k) notice is intended for the following dental indications on intraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): frenctomy, frenotomy, biopsy, operculectorny, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy and pulpotomy as an adjunct to root canal therapy. The Ceralas DlO Diode laser is indicated for the following dental indications on intraoral and extraoral soft tissue (including marginal and interdental gingiva : and epithelial lining of free gingiva); frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor sites, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, and pulpotomy as an adjunct to root canal therapy.

The Cerals D10 Diode Laser operates with a power range of 1-10W in the CW or pulsed mode. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end.

The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System that has already been cleared by FDA (K983058) for use in the following dental indications: draining fistulas, coagulation and decontamination of extraction sites, frenectomy, excisional biopsy, operculectomy, implant uncovering, gingivectomy, gingivoplasty, degranulation of infrabony defects, enucleate apical troughing for crown and bridge, apthus ulcers, crown lengthening, hemostasis of donor sites, removal of granulation tissue, laser assisted flap surgery, exposure of enamel for orthodontic brackets, and surgical exposure to aid in eruption. The purpose of this submission is to expand the indications for use to include pulpotomy and pulpotomy as an adjunct to root canal therapy.

The Cerals D Diode Laser operates with a power range of 1-15W in the CW or pulsed mode. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end.

The Ceralas H Laser System is a surgical instrument indicated to treat leg veins in dermatology and plastic surgery procedures. Specific indications for the Ceralas H Laser System include the treatment of leg veins. The Ceralas H 808nm Diode Laser System is indicated to treat leg veins in dermatology and plastic surgery procedures.

The Ceralas H Laser System is a complete, self-contained compact surgical laser that utilizes gallium alumnum arsenide (GaAlAs) semiconductor diodes to generate near-infrared laser radiation. The laser system consists of a console, footswitch, and handpiece which are connected to the device's console. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The handpiece is placed against the patient's skin and a pulse of light is delivered to the skin surface when the footswitch and handpiece trigger are depressed. The wavelength for the Ceralas H Laser System is 808 ± 20nm. The laser delivers pulsed light with a selectable pulse duration of 5-30 millsseconds and a fluence of 10-40J/cm2. The corresponding pulse energy delivered through the 9x9mm handpiece is 8-32 Joules. The laser pulses are generated at a maximum pulse repetition frequency of up to 1 Hz. Additionally, the software and software development activities are in accordance with FDA's guidance document. "Reviewer Guidance For Computer Controlled Medical Devices Undergoing 510(k) Review."

The Ceralas D Laser System is indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions: papillectomy: vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth: leukoplakia; removal of hyperplastic tissues; treatment of aphthous ulcers; and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

The Ceralas D Laser System is a complete self-contained compact surgical laser that utilizes gallium aluminum arsenide (GaAlAs) semiconductor diodes to generate near-infrared laser radiation. The laser employs a modular design comprised of: (1) a laser diode; (2) a cooling module containing the laser diode, thermoelectric coolers, heat sink fins and fans; (3) an optics module containing a beamsplitter for control of optical power; (4) front control and display panel; and (5) RFI-shielded, transformer power supply and control electronics. Interchangeable fiber optic delivery systems are coupled to the laser via an SMA 905 connector to deliver laser radiation to the target tissues. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The wavelength for the Ceralas D Laser System is 980 ± 30nm, and its laser aiming beam wavelength is 635nm+10nm. The power output ranges from 1-15 Watts. The delivery systems for the Ceralas D Laser System consist of an optical fiber fitted with an SMA 905 connector at the proximal end. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath.

Intended to be used as a fiber optic delivery system handpiece with the capability to be reused with a disposable optical fiber.

The MegaBeam Reusable Fiber Optic Handpiece and Needles are designed to be used with the company's cleared disposable MegaBeam Fiber Optic Delivery Systems which are intended to vaporize, coagulate, incise and excise tissue and which are designed for any indication for which compatible laser systems have been cleared by FDA. The needle is available with 0°, 15°, 30° and 70° angles. They are designed to fit 400 micron, 600 micron, 800 micron and 1000 micron disposable optical fibers. The labeling includes instructions for sterilizing the devices using EtO or steam. The needle is attached to the handpiece by a threaded connector. The fiber optic is then threaded through the handpiece and needle. At the end of the procedure, the fiber optic is discarded and the handpiece and needle are reusable.