# K182270: Cellene CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Med USA, Inc.
- Decided: Nov 2, 2018 after 72 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K936109 (1994). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103501: Alma Lasers Pixel CO2 Laser System, Delivery Device and Accessories, Alma Lasers, Inc. (2011) Summary page 7.

## Indications for use
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 and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of: benign/malignant vascular/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; adult and juvenile papillomatosis polyps; 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 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 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; 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 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, partial glossectomy; 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 (l&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; hysterectomy. 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 of soft tissue in orthopedic surgery. Applications include: Arthroscopy, menisectomy, 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.

Source page: https://510kreport.com/device/K182270
Methodology: https://510kreport.com/methodology