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The Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.

The Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers are indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery. orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery 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 &/or vaporization) for treatment of: wrinkles, rhytids, and furrows. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, &/or treatment of: keratoses, including actinic keratosis; solar/actinic elastosis; cheilitis, including actinic cheilitis; lentigines; uneven pigmentation/ dyschromia; acne scars; surgical scars: keloids; hemangiomas (including Buccal and port wine); tattoos: telangiectasia; removal of small skin tumors; superficial pigmented lesions; adenosebaceous hypertrophy; rhinophyma reduction; cutaneous papilloma (skin tags); milia: debridement of eczematous or infected skin; basal and squamous cell carcinoma; nevi, including spider and epidermal; neurofibromas; tricoepitheliomas; xanthelasma palpebrarum; syrinqoma. 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. Laser incision &/or excision of soft tissue for the performance of blepharoplasty. Laser incision &/or excision of soft tissue for the creation of recipient sites for hair transplantation.

Podiatry: Laser ablation, vaporization &/or excision of soft tissue for the reduction, removal. &/or treatment of: verrucae vulgares/plantar (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 and partial matrixectomy.

Otolaryngology (ENT): Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for 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 nodules and polyps; 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; stenosis, including subglottic stenosis; tonsillectomy (including tonsilar cryptolysis and neoplasma); pulmonary bronchial and tracheal lesion removal; benign and malignant nodules and tumors (larynx, pharynx, trachea); benign and malignant lesions (nose and nasal passages): benign and malignant tumors (oral); stapedotomy/stapedectomy: acoustic neuroma in ear; superficial lesions of the ear; telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); cordectomy and cordal lesions of larynx, pharynx and trachea: myringotomy/tympanostomy; uvulopalatoplasty (LAUP, laser UPPP); turbinectomy: partial glossectomy; tumor resection on oral, subfacial and neck tissues; rhinophyma; verrucae vulgares (warts); qinqivoplastv/ginqivectomy.

Gynecology: Laser incision, ablation and/or vaporization of soft tissue in GYN for treatment of: conization of the cervix, including cervical intraepithelial neoplasia (CIN), 1 vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); condyloma acuminata, including cervical, genital, vulvar and perineal: leukoplakia (vulvar dystrophies); incision and drainage of Bartholin's and nabothian 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; fimbroplasty: metroplasty; microsurgery (tubal); uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy.

Neurosurgery: Laser incision, excision, 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 (e.g. 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.

Orthopedics: Incision/excision and vaporization of soft tissue in orthopedic surgery. Applications include: 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/Thoracic Surgery: 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; cvsts: 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: qingivectomy- removal of hyperplasias; qingivoplasty: 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.

Genitourinary: Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include: benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia.

The Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories are intended to be used to deliver carbon dioxide light energy for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in a variety of medical specialties.

Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers are comprised of the following main components:

• a laser console s
• a laser console tower ・
• a counterbalanced articulated arm and delivery system -
• control and display panel ।
• system microprocessor control electronics -
• a covered footswitch or handswitch for specific delivery device ・ accessories
• an optional air purge pump system with an insufflator filter for purge of ﺘ delivery device accessories
• operating software ﺳ
• a variety of delivery device accessories or handpieces, including a pattern generator

The provided document is a 510(k) Summary Statement for the Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria in the way a clinical trial might.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and reported device performance (in terms of clinical efficacy or specific quantifiable metrics beyond listing indications for use).
• Sample size used for a test set.
• Data provenance (e.g., country of origin, retrospective or prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Information about a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Information about standalone (algorithm only) performance studies.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance evaluation studies.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared devices. This is a regulatory pathway where the new device is shown to be as safe and effective as another legally marketed device without requiring extensive de novo clinical trials.

The document indicates the following:

1. Predicate Devices:
The Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers are substantially equivalent to:

• Lumenis, Inc. (formerly Coherent Medical Group) UltraPulse S Series Carbon Dioxide Surgical Lasers (K974789)
• Lumenis, Ltd. (formerly Sharplan Lasers, Inc.) Model 700 and 1000 Series CO2 Surgical Lasers (K935563)
• Lumenis, Ltd. (formerly Sharplan Lasers, Inc.) Model 20c, 30c and 40c CO2 Surgical Lasers (K963229)
• Lumenis, Ltd. (formerly Sharplan Lasers, Inc.) Model 1080 CO2 Surgical Laser System (K933918)
• Lumenis, Ltd. (formerly ESC Medical Systems) Luxar modified LX-20 CO2 Surgical Laser System (K991628)
• Aesculap-Meditec MultiPulse CO2 Laser (K983215)
• MedArt® Corp. Uni-Laser 450-P CO2 Laser System (K991297)

The modified Delivery Device Accessories are substantially equivalent to:

• Focused spot handpieces with reusable and single-use tip accessories (K933918)
• Fiber/Waveguide handpieces (K900076 and K950725)
• Scanner devices (K955621, K960521 and K963339)
• Scanner handpieces (K951204 and K963229)
• Bronchoscopes and accessories (K822136 and K943700)
• Micromanipulators (K933918, K881953 and K951204)

The Lumenis Stand-Alone Air Purge Pump and Related Accessories are substantially equivalent to:

• Lumenis gas purge accessories previously cleared in K951812

2. Indication for Use:
The device is indicated for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in a wide variety of medical specialties, including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery, and genitourinary surgery. A comprehensive list of specific procedures within these specialties is provided across multiple pages.

Conclusion:
This submission relies on the concept of substantial equivalence to existing, legally marketed devices. The "study" that proves the device meets acceptance criteria is implicitly the demonstration that its technological characteristics, materials, and intended uses are sufficiently similar to predicate devices that have already been deemed safe and effective by the FDA. There is no independent clinical study described in this 510(k) summary with specific acceptance criteria that would typically be evaluated in a clinical trial.

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