(85 days)
The intended use of the AcuPulse series is for the vaporization, incision, excision, ablation, or coagulation of soft tissue in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics. General Surgery and Podiatry.
The intended use of the AcuPulse series is for the performance of specific surgical applications in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Orthopedics, General Surgery and Podiatry as follows:
Dermatology
The AcuPulse laser is indicated for use in dermatology and plastic surgery for the following applications.
- Ablation, vaporization, excision, incision, and coagulation of soft tissue in the performance of:
- Laser skin resurfacing
- Laser dermabrasion
- Laser burn debridement
- Laser skin resurfacing (ablation and/or vaporization) for the treatment of:
- Wrinkles, rhytids, and furrows (including fine lines and texture irregularities)
- Laser skin resurfacing (ablation, and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- Keratoses. including actinic and sebortheic keratosis, seborrhoecae vulgares, seborrheic wart and verruca seborrheica
- Vermillionectomy of the lip
- Cutaneous horns
- Solar/actinic elastosis
- Cheilitis, including actinic cheilitis
- Lentigines, including lentigo maligna or Hutchinson's malignant freckle
- Uneven pigmentation/dyschromia
- Acne scars
- Surgical scars
- Keloids including acne keloidalis nuchae
- Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telangiectaticum)
- Tattoos
- Telangiectasia
- Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
- Superficial pigmented lesions
- Adenosebaceous hypertrophy or sebaceous hyperplasia
- Rhinophyma reduction
- Cutaneous papilloma (skin tags)
- Milia
- Debridement of eczematous or infected skin
- Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
- Nevi, including spider, epidermal and protruding
- Neurofibromas
- Laser de-epithelialization
- Tricoepitheliomas
- Xanthelasma palpebrarum
- Syringoma
- Laser ablation, vaporization, and/or excision for complete and partial nail matrixectomy
- Vaporization/coagulation of:
- Benign/malignant vascular/avascular skin lesions
- Moh's surgery
- Lipectomy
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts
- Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty
- Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation
Podiatry
The AcuPulse laser is indicated for use in podiatry for the following applications:
- Laser ablation, vaporization and/or excision of soft tissue for the reduction, removal, and/or treatment of:
- Verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts
- Fungal nail treatment
- Porokeratoma ablation
- Ingrown nail treatment
- Neuromas/fibromas, including Morton's neuroma
- Debridement of ulcers
- Other soft tissue lesions
- Laser ablation, vaporization, and/or excision for complete and partial (nail) matrixectomy
Otolaryngology (ENT)
The AcuPulse laser is indicated for laser incision, ablation, and/or vaporization of soft tissue in otolaryngology for the treatment of:
- Choanal atresia
- Leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue
- Nasal obstruction
- Adult and juvenile papillomatosis polyps
- Polypectomy of nose and nasal passages
- Lymphangioma removal
- Removal of vocal cord/fold nodules, polyps and cysts
- Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords
- Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue
- Zenker's Diverticulum/ pharyngoesophageal diverticulum [endoscopic laser-assisted esophagodiverticulostomy (ELAED)]
- Stenosis, including subglottic stenosis
- Tonsillectomy (including tonsilar cryptolysis and neoplasma) and tonsil ablation/tonsillotomy
- Pulmonary bronchial and tracheal lesion removal
- Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial)
- Benign and malignant lesions and fibromas (nose and nasal passages)
- Benign and malignant tumors and fibromas (oral)
- Acoustic neuroma in the ear
- Superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease
- Telangiectasia/hemangioma of larynx, pharynx, and trachea (includes uvula, palatal, or upper lateral pharyngeal tissue)
- Cordectomy, cordotomy (for the treatment of vocal fold motion impairment), and cordal lesions of larynx, pharynx, and trachea
- Myringotomy/tympanostomy (tympanic membrane fenestration)
- Uvulopalatoplasty (LAUP, laser UPP)
- Turbinectomy and turbinate reduction/ablation
- Septal spur ablation/reduction and septoplasty
- Partial glossectomy
- Tumor resection of oral, subfacial and neck tissues
- Rhinophyma
- Verrucae vulgares (warts)
- Gingivoplasty/gingivectomy
Gynecology and GYN Laparoscopy Indications
The AcuPulse laser is indicated for use in gynecology for the following applications:
- Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:
- Conization of the cervix, including cervical intraepithelial neoplasia (CIN), and vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
- Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowenoid papulosa (BP) lesions
- Leukoplakia (vulvar dystrophies)
- Incision and drainage (I&D) of Bartholin's and nabothian cysts
- Herpes vaporization
- Urethral caruncle vaporization
- Cervical dysplasia
- Benign and malignant tumors
- Hemangiomas
- Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including gynecological laparoscopy, for the treatment of:
- Endometrial lesions, including ablation of endometriosis
- Excision/lysis of adhesions
- Salpingostomy
- Oophorectomy
- Fimbrioplasty
- Metroplasty
- Microsurgery (tubal)
- Uterine myomas and fibroids
- Ovarian fibromas and follicle cysts
- Uterosacral ligament ablation
- Hysterectomy
Neurosurgery Indications
The AcuPulse laser is indicated for laser incision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of:
- Cranial
- Posterior fossa tumors
- Peripheral neurectomy
- Benign and malignant tumors and cysts, for example, gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors
- Arteriovenous malformation
- Pituitary gland tumors (transphenoidal approach)
- Spinal Cord
- Incision/excision and vaporization of benign and malignant tumors and cysts
- Intra- and extradural lesions
- Laminectomy/laminotomy/microdiscectomy
Orthopedic Indications
The AcuPulse laser is indicated for incision, excision, and vaporization of soft tissue in orthopedic surgery, including the following applications:
- Arthroscopy
- Meniscectomy
- Chondromalacia
- Chondroplasty
- Ligament release (lateral and other)
- Excision of plica
- Partial synovectomy
- General
- Debridement of traumatic wounds
- Debridement of decubitus and diabetic ulcers
- Microsurgery
- Artificial joint revision
- PMMA removal
General and Thoracic Surgery
The AcuPulse laser is indicated for incision, excision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures. Applications include:
- Debridement of decubitus ulcers, stasis, diabetic, and other ulcers
- Mastectomy
- Debridement of burns
- Rectal and anal hemorrhoidectomy
- Breast biopsy
- Reduction mammoplasty
- Cytoreduction for metastatic disease
- Laparotomy and laparoscopic applications
- Mediastinal and thoracic lesions and abnormalities
- Skin tag vaporization
- Atheroma
- Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips
- Pilonidal cyst removal and repair
- Abscesses
- Other soft tissue applications
Dental and Oral Surgery
The AcuPulse laser is indicated for incision, excision, and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- Gingivectomy/removal of hyperplasias
- Gingivoplasty
- Incisional and excisional biopsy
- Treatment of ulcerous lesions, including aphthous ulcers
- Incision of infection when used with antibiotic therapy
- Frenectomy (frenum release)
- Excision and ablation of benign and malignant lesions
- Homeostasis
- Operculectomy
- Crown lengthening
- Removal of soft tissue, cysts, and tumors
- Oral cavity tumors and hemangiomas
- Abscesses
- Extraction site hemostasis
- Salivary gland pathologies
- Preprosthetic gum preparation
- Leukoplakia
- Partial glossectomy
- Periodontal gum resection
The AcuPulse 30 and 40 series is the next generation of Lumenis CO2 lasers. The new product will retain the same console, articulated arm, delivery devices and other basic features of the current Compact 20C, 30C & 40C series, while integrating improved versions of the GUI and SurgiTouch scanner currently used with the UltraPulse SurgiTouch.
The AcuPulse 30 and 40 Carbon Dioxide Laser is an advanced computer-controlled, user friendly CO2 laser system based on a sealed-off CO2 laser tube providing up to 30 or 40 Watts (model dependent) on tissue. The system incorporates the CO2 laser tube within the main cabinet, an articulated arm beam delivery system and attachable laser accessories. The system is activated for laser emission by a footswitch.
This system incorporates a DC-excited CO2 laser tube. The CO2 laser wavelength falls in the mid-infrared region of the electromagnetic spectrum. This wavelength is invisible to the human eye. CO2 laser energy is readily absorbed by water in tissue. Since soft tissue is comprised primarily of water, CO2 laser energy can be used effectively for the excision, incision, ablation, vaporization and coagulation of soft tissue
The provided text describes the AcuPulse 30 and 40 Carbon Dioxide Laser System and its intended use, but it does not contain information about acceptance criteria for device performance or any study conducted to prove the device meets specific performance criteria.
Instead, the document is a 510(k) summary for regulatory clearance, primarily focused on demonstrating "substantial equivalence" to predicate devices. This means the manufacturer is asserting their new device is as safe and effective as a device already legally marketed. The core claim is that:
- "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the AcuPulse 30 and 40 Carbon Dioxide Laser System has been conducted." (Page 9)
This statement indicates that internal testing was done, but the details of that testing, including specific acceptance criteria, study methodology, sample sizes, ground truth establishment, or expert involvement, are not provided in this 510(k) summary.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study details based on the information given. The document focuses on regulatory classification, intended use, and comparison to predicate devices, not on detailed performance study results against predefined acceptance criteria.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.