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The Uni-Laser™ 430 is intended for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels)

In contact mode the Uni-Laser 430 can be used for vaporization, ablation, incision, and excision of soft tissue.

MedArt Corporation Uni-Laser™ 430

This document is a 510(k) clearance letter from the FDA for the MedArt Corporation Uni-Laser™ 430. It focuses on the regulatory approval of the device and its intended uses.

Unfortunately, this document does not contain the specific information required to answer your questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The provided text only states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use: hair removal in skin types I-IV, and soft tissue applications like coagulation of vascular lesions, and in contact mode for vaporization, ablation, incision, and excision of soft tissue.

To answer your questions, I would need a different type of document, such as:

• A clinical study report for the MedArt Corporation Uni-Laser™ 430.
• A detailed technical data submission to the FDA by MedArt Corporation.
• A performance testing report for the device.

Without such documentation, I cannot provide the requested information.

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The Uni-laser 425P Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include:

Dermatology and Plastic Surgery for

Photocoagulation of dermatological vascular lesions Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions

Dentistry (soft tissue only), including sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), and oral surgery; Ear Nose & Throat; Otorhinolaryngology; Neurosurgery (coagulation only); Ophthalmology/Oculoplastic; Pulmonary/Thoracic Surgery;

Gastroenterology; Urology; Gynecology; Orthopedics; Podiatry; and General Surgery.

Uni-Laser 425P™ Diode Laser System and Accessories

This document is a marketing clearance letter from the FDA for the Uni-Laser 425P™ Diode Laser System and Accessories (K991659). It primarily states that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document does not contain information about:

• Acceptance criteria or reported device performance.
• Any specific study design, sample sizes, data provenance, expert qualifications, or ground truth establishment.
• Comparative effectiveness studies (MRMC) or standalone algorithm performance.

Therefore, I cannot provide the requested table or detailed study information based on the provided text. The document confirms the device's regulatory clearance but does not delve into the technical details of its performance testing.

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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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