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The Uni-laser 450P CO2 Laser System & Accessories are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open and endoscopic general surgery.

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

Treatment of wrinkles, rhytids and furrows

Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas) tattoos, telangiectasia, squarnous and basal cell carcinoma, spider and epidermal nacvi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.

Dermatology, Plastic Surgery & General Surgery Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.

Soft Tissue Dental The specific soft tissue dental indications include: Periodontic procedures such as gingivectomy-removal of hyperplasias, gingivoplasty, and incision and excision:

Oral Surgery such as frenectomy, incisional and excisional biopsy, incision and excision of aphous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, homeostasis, operculectorny, and crown lengthening.

Podiatry Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy.

Otorhinolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia g larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillornatosis politic rhinophyma and verrucae vulgares.

Gynecology Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia.

Neurosurgery Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large turnors.

The Uni-laser 450P CO2 Laser System & Accessories are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open and endoscopic general surgery.

The provided document is a 510(k) clearance letter from the FDA for the Uni-Laser 450P CO2 Laser System & Accessories. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to legally marketed devices prior to May 28, 1976, based on the indications for use stated in the enclosure. It outlines general controls and regulations the manufacturer must comply with but does not provide specific details on performance testing or acceptance criteria.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a premarket approval (PMA) submission, or a clinical study report, which typically include detailed performance data and acceptance criteria. This 510(k) clearance letter primarily focuses on regulatory approval based on substantial equivalence, not on a detailed analysis of a device's performance against specific acceptance criteria.

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