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The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only).

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: orthopedics.

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems are indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, orthopedics, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only) as follow:

Gastroenterology
The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include:

• hemostasis of esophageal varices:
• palliation of malignant dysphagia:
• palliative ablation of obstructive neoplasms; -
• hemostasis of colonoscopy.
• = hemostasis of upper and lower GI bleeding (810 nm or 980 nm only);
• excision and vaporization of colorectal carcinoma (810 nm or 980 nm only);
• .. excision of polyps (810 nm or 980 nm only).

Neurosurgery
The hemostasis, ablation, vaporization, excision, and coagulation of soft tissue in neurosurgery procedures. Applications include:

• tumors adjacent to the spinal cord;
• tumors adjacent to the cortex.

General Surgery, Aesthetic (Dermatology and Plastic Surgery), and Podiatry
Treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein.

The hemostasis, ablation, vaporization, excision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include:

• Laparoscopic
• appendectomy; -
• cholecystectomy; -
• bowel resection.
• Open
• mastectomy; ・
• reduction mammoplasty; ー
• breast biopsy;
• rectal and anal hemorrhoidectomy; -
• bowel resection; -
• ー colectomy:
• cholecystectomy; "
• liver resection: -
• condyloma:
• thyroidectomy; -
• thoracotomy; -
• cavernous hemangioma;
• Open (810 nm or 980 nm only)
• matrixectomy; -
• excision of neuromas;
• excision of perifungual & subungual warts; -
• excision of plantar warts; -
• excision of keloids -
• excision of cutaneous lesions; -
• debridement of decubitus ulcer; -
• hepatobillary tumors; -
• dermabrasion; -
• vaporization & hemostasis of capillary hemangioma; -
• excision, vaporization, & hemostasis of abdominal turnors;
• excision, vaporization & hemostasis of rectal pathology; -
• pilondial cystectomy; -
• herniorrhaphy; -
• adhesiolysis; -
• parathyroidectomy: -
• thyroidectomy; ।
• resection of organs; -
• debridement of wounds
• photocoagulation of telangiectasia of the legs and face;
• photocoagulation of vascular lesions of the face and extremities.

Genitourinary (Urology)
The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include:

• Transurethral
• transurethral incision of the prostate (TUP); -
• bladder tumors;
• bladder neck incisions;
• removal of bladder neck obstructions (810 nm or 980 nm only); -
• urethral strictures;
• exterior sphincterotomy. |
• vaporization of urethral tumors (810 nm or 980 nm only).
• Laparoscopic
• lymphadenectomy. ー
• -Open
• condyloma; -
• circumcision -
• benign and malignant lesions of external genitalia.

Thoracic Surgery
The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include:

• pulmonary resection:
• coagulation of blebs and bullae; ﮯ
• adhesiolysis; -
• pericardiectomy -
• mediastinal and thoracic lesions and abnormalities; -
• mediastinal lymph node dissection; -
• thoracotomy. -

Gynecology (GYN)
The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include:

• Laparoscopic
• excision/lysis of adhesions; -
• endometrial lesions, including ablation of endometriosis; -
• laparoscopic assisted hysterectomy (LAVH); -
• laser uterosacral nerve ablation (LUNA); -
• myomectomy; -
• ovarian cystectomy; -
• ovarian drilling;
• tubal fimbrioplasty; -
• appendectomy; 1
• menorrhagia (810 nm or 980 nm only).
• Open
• conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN;
• condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen 's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions.
• Intrauterine
• fibroids/polyps/adhesions: -
• resection of septum. 工

Pulmonology
The hemostasis, ablation, vaporization, excision, and coagulation of soft tissue in pulmonology procedures. Applications include:

• tracheal bronchial lesions.
• tracheobronchial malignancy or stricture; (810 nm or 980 nm only) "
• benign and malignant pulmonary obstruction; (810 nm or 980 nm only)
• endoscopic pulmonary applications. (810 nm or 980 nm only)

Ophthalmology
The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include:

• Oculoplastics
• open DCR; -
• endo-nasal DCR;
• tumor excision and biopsy;
• eyelid reconstruction; -
• blepharoplasty. -

Orthopedics
The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures and arthroscopy; and the hemostasis of soft tissue in arthroscopy. Applications include:

• Open
• dissect and coagulate. -

Otolaryngology (ENT)
The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include:

• Nasal/Sinus
• turbinectomy and turbinate reduction/ablation; -
• polypectomy of nose and nasal passages; -
• ethmoidectomy; -
• meatal antrostomy;
• Laryngo-tracheal
• removal of vocal cord/fold nodules, polyps and cysts; -
• arytenoidectomy; -
• tracheal stenosis; -
• Oropharyngeal
• uvulopalatoplasty (LAUP, laser UPPP):
• tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; ﺖ
• hemi glossectomy; …

Head & Neck -

• tumor resection on oral, subfacial and neck tissues; -
• parathyroidectomy; ﺳ
• thyroidectomy. -

Laser Assisted Lipolysis (980 nm only)

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems are designed to provide laser power at wavelengths of 810nm, 940nm, and 980nm, depending on model, which can be used for the procedures indicated in the next section of this summary. These devices have been cleared previously via K. 040294 and K042211. Differences between the cleared and modified device are limited to:

• Addition of Laser Assisted Lipolysis to the indications of use of the LaserPro 980 Surgical Diode Laser Systems previously cleared via K040294 and K042211.
• • Addition of several other indications for use to the indications for use of the LaserPro 810, 940 & 980 Surgical Diode Laser Systems previously cleared via K040294 and K042211.

The system is comprised of the following main components:

• . A laser console/cabinet with fiber port to accept SMA-905 connectors.
• Display panel with soft-touch keypad control and separate Emergency Off . button.
• Laser system microprocessor control electronics with operating software .
• A detachable covered footswitch. .

The provided 510(k) summary for the PhotoMedex LaserPro 810, 940, and 980 Surgical Diode Laser Systems does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics.

This document is a 510(k) Premarket Notification to the FDA, which is a submission to demonstrate that the device is substantially equivalent to a legally marketed predicate device. In this context, "safety and effectiveness" are asserted by demonstrating substantial equivalence, not by presenting new performance data against acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement, as this information is not present in the provided text.

The document focuses on:

• Device Description: What the device is and its modifications.
• Indications for Use: The medical applications for which the device is intended.
• Predicate Devices: Other similar devices already cleared by the FDA to which this device claims substantial equivalence.
• Substantial Equivalence Argument: The claim that the new device is as safe and effective as the predicate devices because it shares similar indications, design, and functional features.

The letter from the FDA confirms their finding of substantial equivalence based on the provided information, allowing the device to be marketed. It does not refer to any specific performance studies or acceptance criteria described within this summary.

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