(154 days)
The Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knec).
The Alma Lasers ThermoXEL™ CO2 Laser System is cleared for use for the particular indications as follows:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- laser skin resurfacing
- laser derm-abrasion
- laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) for the treatment of:
- wrinkles, rhytids, and furrows (including fines lines and texture irregularities)
Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.
Dermatology & Plastic Surgery, continued
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, sebortheic wart, and verruca seborrheica;
- vermillionectomy of the lip;
- cutaneous horns;
- solar/actinic elastosis;
- chelitis, including actinic chelitis;
- 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 telagiectaticum);
- 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;
Dermatology & Plastic Surgery, continued
- nevi, including spider, epidermal and protruding;
- neurofibromas;
- laser de-epithelialization;
- tricoepitheliomas;
- xanthelasma palpebrarum;
- syringoma
Laser ablation, vaporization and /or excision for complete or partial nail matrixectorny.
Vaporization/coagulation of:
- benign/malignant vascular/avascular skin lesions;
- Moh's Surgery;
- Lipectomy;
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungaual warts.
Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and /or excision o soft tissue for the creation of recipient sites for hair transplantation.
Podiatry
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 in podiatry for complete or partial matrixectomy.
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
- choanal atresia,
- leukoplakia, including oral, larynx, uvula, palatal, 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;
Otolaryngology (ENT), continued
- laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue;
- Zenker's Diverticulum/pharyngoesophageal diverticulum Jendoscopic laser-assisted esophagodivertuculostomy (ELAED)};
- stenosis, including subglottic stenosis;
- tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy;
- pulmonary bronchial and tracheal lesion removal;
- benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, trachcobronchial/endobronchial);
- benign and malignant lesions and fibromas (nose and nasal passages);
- benign and malignant tumors and fibromas; (oral);
- stapedotomy/stapedectomy;
- 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 paralysis/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 on oral, subfacial and neck tissues;
- rhinophyma:
- verrucae vulgares (warts);
- gingivoplasty/gingivoctomy.
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of;
- conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
- condyloma acuminate, including cervical, genital, vulvar, perincal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;
- leukoplakia (vulvar dystrophies);
- incision and drainage (I&D) of Bartholin's and nubuthian cysts;
- herpes vaporization;
- urethral caruncle vaporization;
- cervical dysplasia;
- benign and malignant tumors;
- hemangiomas.
GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:
- endometrial lesions, including ablation of endometriosis;
- excision/lysis of adhesions;
- salpingostomy;
- oophorectomy/ovariectomy:
- fimbroplasty:
- metroplasty:
- microsurgery (tubal);
- uterine myomas and fibroids;
GYN Laparoscopy, continued
- ovarian fibromas and follicle cysts;
- uterosacral ligament ablation;
- hysterectomy.
Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:
Cranial
- posterior fossa tumors;
- peripheral neurectomy;
- benign and malignant tumors and cysts (e.g. gliomas, menigiomas (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.
Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:
Arthroscopy
- menisectomy;
- chodromalacia;
- chondroplasty;
- ligament release (lateral and other);
- excision of plica;
- partial synovectomy.
General
- deridement of traumatic wounds;
- debridement of decubitus and diabetic ulcers;
- microsurgery;
- artificial joint revision;
- PMMA removal.
General/Thoracic Surgery
Incision, excision and vaporization and 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;
General/Thoracic Surgery, continued
- 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/Oral Surgery
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;
Dental/Oral Surgery, continued
- 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.
Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:
- benign and malignant lesions of external genitalia;
- condyloma;
- phimosis
- erythroplasia.
The Alma Lasers ThermoXEL™ CO2 Laser System Pixel Handpieces are indicated for use in soft tissue for:
Dermatology & Plastic Surgery
- Skin resurfacing
The Alma Lasers ThermoXEL™ CO2 Laser System and delivery device accessories consist of the following major components:
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- Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
- a. LCD control panel
- b. Keypad
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- 7-joint articulated arm
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- Footswitch
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- Variety of Delivery Device Handpieces (single spot, scanner, pixel)
This submission is a 510(k) premarket notification for the Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)). The FDA's substantial equivalence determination for this device is primarily based on its similarity in indications for use, operation, and technical/functional capabilities to predicate devices already on the market.
Therefore, this document does not contain information about specific acceptance criteria or an independent study to prove that the device meets those criteria. Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices. Consequently, I am unable to provide the detailed information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or specific study designs.
The relevant sections of the document are:
- Section VII. Safety and Effectiveness Information: This section states that "The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories are substantially equivalent to the predicate devices." This is the core of their "proof" of effectiveness and safety, relying on comparison to already approved devices rather than a de novo study.
- Section III. Predicate Devices: This lists the devices to which Alma Lasers ThermoXEL™ is claiming substantial equivalence.
Without a direct study of the device against predefined acceptance criteria, I cannot complete the table or answer the specific questions about study design, sample sizes, ground truth, or expert involvement as those details are not provided in a 510(k) submission focused on substantial equivalence.
§ 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.