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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 ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary (urology), thoracic surgery, gynecology (GYN), pulmonology, ophthalmology, and orthopedics, and otolaryngology (ENT).

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems are indicated for use in the performance of specific surgical applications in gastroenterology, neurosurgery, general surgery, genitourinary (urology), thoracic surgery, gynecology (GYN), pulmonology, ophthalmology, and orthopedics, and otolaryngology (ENT) as follows:

Gastroenterology
The 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.

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

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

General Surgery
Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.
The ablation, vaporization, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include:

• Laparoscopic
  • appendectomy;
  • cholecystectomy;
  • bowel resection.
• Open
  • mastectomy;
  • reduction mammoplasty;
  • breast biopsy;
  • rectal and anal hemorrhoidectomy;
  • bowel resection;
  • colectomy;
  • cholecystectomy;
  • liver resection;
  • condyloma;
  • thyroidectomy;
  • thoracotomy;
  • cavernous hemangioma.

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

• Transurethral
  • transurethral incision of the prostate (TUIP);
  • bladder tumors;
  • bladder neck incisions;
  • urethral strictures;
  • exterior sphincterotomy.
• Laparoscopic
  • Lymphadenectomy.
• Open
  • condyloma;
  • circumcision
  • benign and malignant lesions of external genitalia.

Thoracic Surgery
The 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;
• adhesiolysis;
• pericardiectomy
• mediastinal and thoracic lesions and abnormalities;
• mediastinal lymph node dissection;
• hemostasis;
• thoracotomy.

Gynecology (GYN)
The 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.
• 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.

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

• tracheal bronchial lesions.

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. Applications include:

• Open
  • Dissect and coagulate.

Otolaryngology (ENT)
The 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;
  • hemi glossectomy;
• Head & Neck
  • tumor resection on oral, subfacial and neck tissues;
  • parathyroidectomy;
  • thyroidectomy.

The PhotoMedex LaserPro 810, 940 and 980 Diode Laser Systems are designed to provide laser power at wavelengths of 810mm, 940mm, and 980mm, 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 K040294. Differences between the cleared and modified device are limited to:

• Maximum output power increased from 20 to 25 Watts (Systems are identified by output frequency and maximum power).
• User adjustable (intensity) aiming beam (the maximum aiming beam optical power does not change from currently cleared device).

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 document is a 510(k) Summary for the PhotoMedex LaserPro 810, 940 and 980 Systems Diode Laser Systems, submitted to the FDA for premarket notification. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to prove safety and effectiveness.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in a clinical study for several reasons:

• Substantial Equivalence: The submission is based on the concept of "substantial equivalence" to previously cleared devices (K040294, K023543, K954316, K952661). This means PhotoMedex is asserting that their modified devices (with increased maximum output power and user-adjustable aiming beam) are as safe and effective as the predicate devices, and perform similarly. They are not introducing "new clinical indications" that would necessitate new performance criteria or efficacy studies.
• Safety and Effectiveness Justification: Section 7, "SAFETY AND EFFECTIVENESS," explicitly states: "The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed... with both mandatory and voluntary and voluntary Standards ensuring when used with marketed cleared delivery systems identified to be chisating when are considered both safe and effective for the medical applications indicated. No new clinical indications are to be provided by the introduction of LaserPro Diode Surgical Lasers as compared to the identified predicates, which havel previously demonstrated clinical effectiveness." This indicates that the safety and effectiveness are established by adherence to standards and the prior clearance of predicate devices for similar indications.
• No Clinical Study Details: The document makes no mention of any new human subject clinical trials, test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance studies. These are typically associated with novel devices or significant changes requiring new performance validation.

Given the nature of a 510(k) for minor modifications to an existing device and the explicit statements in the document, it is not possible to extract the requested information. The "study that proves the device meets the acceptance criteria" in this context is implicitly the historical data and regulatory clearances of the predicate devices.

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