NATURALASE LP ND:YAG LASER

{0}------------------------------------------------ K031828 1 2 4 # JUL 17 2003 ## SECTION 10 ## 510(k) SUMMARY This 510(k) summary of safety and effectiveness for the Focus Medical NaturaLase L.P Laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary. - Focus Medical Applicant: 23 Francis J. Clarke Circle Address: Bethel, CT 06801 Focus Medical, LLC Manufacturer: 23 Francis J. Clarke Circle Bethel, CT 06801 Mr. John B. Lee, Jr. Contact Person: President Focus Medical 203-730-8885 Telephone: Preparation Date: June 2003 (of the Summary) NaturaLase LP Laser Device Name: Common Name: Nd:YAG Long Pulse Laser Classification: Laser surgical instrument for use in general and plastic surgery and in dermatology Class II medical device 21 CFR 878.4810 Product Code: GEX Panel: 79 - Predicate devices: Family of Altus CoolGlide Aesthetic Lasers (K023954, K022226, K014040, K003203), Laserscope Lyra System and Accessories (K003147, K020021, K010834, K990903) and Cynosure Smartepil (K020197). - Device description: The Focus Medical NaturaLase LP Laser in a long-pulse Nd: YAG Laser operating at 1064 nm. {1}------------------------------------------------ K031828 20g 4 # Indications: The Focus Medical NaturaLase LP Laser is indicated for: ### General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology. ### Dermatology/Plastic Surgery: Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins. In addition, the NaturaLase LP is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The NaturaLase LP Laser is also indicated for pigmented lesions to reduce lesion 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. Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery. The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles. The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The NaturaLase LP Laser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The NaturaLase LP Laser is indicated for use on all skin types (Fitzpatrick I - IV) including tanned skin. ### Endoscopic/Laparoscopic Surgery: The NaturaLase LP Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, {2}------------------------------------------------ K0319288 394 cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied. ### Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestinal hemostasis including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, gastrointestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, and hemorrhoids. # General Surgery: Incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids. ## Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum. ## Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis. ## Hemostasis During Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures. ## Neurosurgery: Hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma. ## Oculoplastics: Incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, {3}------------------------------------------------ K031828 4g4 removal of biopsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents. ## Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications. ## Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures. ## Thoracic Surgery: Cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy). ### Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata). - The claim of substantial equivalence is based on Performance Data: None required. comparisons of specifications, characteristics, and indications for use of the claimed predicates. - CONCLUSION: Based on the information in the notification Focus Medical believes that the Focus Medical NaturaLase LP Laser is substantially equivalent to the claimed predicates. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 17 2003 Mr. John Lee, Jr. President Focus Medical LLC 23 Francis J. Clarke Circle Bethel, Connecticut 06801 Re: K031828 Trade/Device Name: Focus Medical NaturaLase LP Nd:YAG Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 13, 2003 Received: June 19, 2003 Dear Mr. Lee: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ Page 2 - Mr. John Lee, Jr. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Miriam C. Provost for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## SECTION 7 # INDICATIONS FOR USE STATEN 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Focus Medical NaturaLase LP Nd;YAG Laser Indications for Use Statement: The Focus Medical NaturaLase LP Laser is indicated for: ### General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology. ### Dermatology/Plastic Surgery: Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangjectasia, rosacea, venus lake, leg and spider veins. In addition, the NaturaLase LP is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The NaturaLase LP Laser is also indicated for pigmented lesions to reduce lesion 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. Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation Prescription Use √ Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) Division of General, Restorative and Neurological Devices 510(k) Number . 060 {7}------------------------------------------------ 2 of 3 ## INDICATIONS FOR USE STATEMENT (continued) The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles. The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The NaturaLase LP i aser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The NaturaLase LP Laser is indicated for use on all skin types (Fitzpatrick I - IV) including tanned skin. # Endoscopic/Laparoscopic Surgery: The NaturaLase LP Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied. ### Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestinal hemostasis including varices, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, gastrointestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, and hemorrhoids. ### General Surgery: Incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids. ### Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum. {8}------------------------------------------------ ## Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis. ## Hemostasis During Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures. ### Neurosurgery: Hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma. ### Oculoplastics: Incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents. ## Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications. ### Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures. ### Thoracic Surgery: Cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy). #### Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).