(72 days)
The Cellene CO2 laser system is indicated 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 (knee).
The Cellene Co2 Laser system is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
The Standard Handpiece of the Cellene Co2 System is indicated for the following:
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 dermabrasion, 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.
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, seborrheic 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; nevi, including spider, epidermal and protruding; neurofibromas; laser de-epithelialization; tricoepitheliomas; xanthelasma palpebrarum; syringoma laser ablation, vaporization for complete or partial nail matrixectomy. Vaporization of: benign/malignant vascular/avascular/avascular skin lesions; Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual wart.
Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of: Verrucae, vulgares / plantars(warts), including paronychial, periungal, and subungual warts, fungal nail treatment, porokeratoma ablation; ingrown nail treatment; neuromas/fibromas,
including morton's neuroma, debridement of ulcers, and 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: leukoplakia, including oral, larynx, uvula, palatal, upper latera pharyngeal tissue; nasal obstruction; x adult and juvenile papillomatosis polyps; x polypectomy of nose and nasal passages; lymphangioma removal; 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; superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease; rhinophyma; verrucae vulgares (warts);
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, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions; leukoplakia (vulvar dystrophies); herpes vaporization, urethral caruncle vaporization, cervical dysplasia, Benign and malignant tumors.
Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: treatment of ulcerous lesions, including aphthous ulcers, excision and ablation of benign and malignant lesions; leukoplakia,
Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures.
Applications include. benign and malignant lesions of external genitalia, condyloma. erythroplasia
The Fractional Handpiece of the Cellene System is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
The Surgical Handpiece of the Cellene Co2 laser System is
Indicated for the following
Dermatology & Plastic Surgery
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
vermillionectomy of the lip; cutaneous horns; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; rhinophyma reduction, basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; neurofibromas
Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of:
benign/malignant vascular/avascular skin lesions: Moh's Surgerv: 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
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; 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, nasal obstruction; adult and juvenile papillomatosis olyps, polypectomy of nose and nasal passages; lymphangioma removal, removal of vocal cord/fold nodules, polyps and cysts; x removal of recurrent , papillomas in the oral cavity, nasal cavity, larynx 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 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, tracheobronchial/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, nodularis 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), vulopalatoplasty (LAUP, laser UPPP); turbinectomy and turbinate reduction/ablation, septal spur ablation/reduction and septoplasty, x partial glossectomy; x tumor resection on oral, subfacial and neck tissues, thimophyma, 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, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions, incision and drainage (1&D) of Bartholin's and nubuthian cysts, 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, fimbrioplasty, metroplasty, microsurgery (tubal);, uterine myomas and fibroids; ovarian fibromas and follicle cysts, uterosacral ligament ablation; hvsterectomy.
Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial
posterior fossa tumors; x 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
Xmenisectomy, chondromalacia, chondrolasty, ligament release ( lateral and other) excision of plica, partial synovectomy. debridement 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 bums; 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/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, 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, 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 Cellene Co2 Laser system is a computer controlled Radio Frequency system that delivery Co2 energy to the target treatment area at 10,600nm wave length using three different Handpieces (Standard, Fractional and Surgical), This Co2 laser energy is absorbed by water in tissue to achieve its intended treatment effects. and system consist of,
laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam,
Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp
This converted light energy creates the C02 laser and exhaust from the crystal and amplified into a specific wave length. Laser energy produced is delivered to the Tissue by means of an articulated arm and a specially designed Hand Piece.
The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
This system also consist of
Optic main Bench assembly, Articulated Arm, 3 Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch,
The provided text is a 510(k) Summary for the Cellene CO2 Laser System. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical studies with acceptance criteria and performance metrics for the Cellene CO2 Laser System itself. It primarily lists the device's intended uses and references standards compliance for safety and essential performance.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly with details about sample size, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, is not available in the provided text.
The document explicitly states: "Clinical test data is not provided in this submission."
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
As stated above, no specific performance acceptance criteria or clinical performance data for the Cellene CO2 Laser System is provided. The submission relies on demonstrating substantial equivalence to a predicate device (K103501 Pixel Co2 System Alma Lasers Inc.) based on similar characteristics and compliance with general safety and performance standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided, as clinical test data was not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided, as clinical test data was not included.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided, as clinical test data was not included.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not done, as clinical test data was not included. The device is a surgical laser, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/done. The Cellene CO2 Laser System is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not provided, as clinical test data was not included.
8. The sample size for the training set
Not applicable, as clinical test data was not included and the device is not an AI/machine learning system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, for the same reasons as above.
Additional details available from the document (regarding general safety and performance, not clinical efficacy):
The device claims to meet the following standards, which can be considered "acceptance criteria" for basic safety and performance, although specific performance metrics against these standards are not detailed in this summary:
- IEC60601-1 part 1: General requirement for basic safety and essential performance
- IEC60601-1-2: 2007: Electro Magnetic Compatibility test
- IEC60601-2-2: Performance of high frequency surgical equipment and accessories
- IEC60601-2-22: Performance of Surgical, Cosmetic, Therapeutic and Diagnostic laser
- IEC60601-1 Part 1-6: General requirement for safety-Collateral Standard: usability
- IEC60825-1, 2nd Ed Part 1: Equipment classification and requirements
- IEC62304: Medical device software- Software life-cycle processes
- Accelerated Aging test of Electrosugrical system electrode hand controlled, general-purpose, single use
Biocompatibility Testing:
For parts having direct contact with patients (Hand Piece Probe, made of PC (Polycarbonate), limited contact
§ 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.