# K042211: Modification to: Laserpro 810, 940, and 980 Diode Diode Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Laser Technologies, Inc.
- Decided: Nov 8, 2004 after 84 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952661 (1995). 4 ancestors in all.
303 later devices descend from it; 3 cite it directly.
0 of 308 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040294: Laserpro Diode Laser Systems, Models 810, 940 & 980, Photo Medex, Inc. (2004) Summary page 1.
- K023543: Evlt Kit and D15PLUS and D30PLUS Diode, Diomed, Inc. (2002) Summary page 3.
- K954316: Aurora Surgical Diode Laser System W/Accessories, Premier Laser Systems, Inc. (1995) Summary page 3.
- K952661: SLT Thermalite Diode Laser Series, Diode 980, 810, 940, Surgical Laser Technologies, Inc. (1995) Summary page 3.

## Most influential descendants
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene (2006), 299 descendants of its own
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), 263 descendants of its own
- K071295: 100W Ceralas D 980NM Diode Laser (2007), 230 descendants of its own
- K072106: 150W Ceralas D 980NM Diode Laser (2007), 229 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own

## Indications for use
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, general surgery, genitourinary surgery (urology), gynecology surgery (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery. The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems are indicated for use in the performance of specific surgical applications in gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery 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, excision, 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 UTPP); - tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; - hemi glossectomy; - Head & Neck - tumor resection on oral, subfacial and neck tissues; - parathyroidectomy; - thyroidectomy.

Source page: https://510kreport.com/device/K042211
Methodology: https://510kreport.com/methodology