# K082721: Laserpro 810, 940 and 980 Diode Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Photo Medex, Inc.
- Decided: Oct 28, 2008 after 41 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 358 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 366 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042211: Modification to: Laserpro 810, 940, and 980 Diode Diode Laser Systems, Surgical Laser Technologies, Inc. (2004) Summary page 1.
- K040294: Laserpro Diode Laser Systems, Models 810, 940 & 980, Photo Medex, Inc. (2004) Summary page 1.
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 1.
- K001975: Ceralas D10 810NM Laser, Model Ceralas D10-60, Ceram Optec, Inc. (2000) Summary page 1.
- K062363: BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM, B&W Tek, Inc. (2007) Summary page 1.
- K954316: Aurora Surgical Diode Laser System W/Accessories, Premier Laser Systems, Inc. (1995) Summary page 1.
- K952661: SLT Thermalite Diode Laser Series, Diode 980, 810, 940, Surgical Laser Technologies, Inc. (1995) Summary page 1.
- K073617: Pharaon Lipo, Osyris (2008) Summary page 1.
- K080567: Palomar Aspire Laser Platform, Palomar Medical Products, Inc. (2008) Summary page 1.
- K081416: Palomar Aspire Laser Platform, Palomar Medical Products, Inc. (2008) Summary page 1.
- K062321: Smartlipo ND:Yag Laser, Cynosure, Inc. (2006) Summary page 1.
- K072751: Cooltouch Models NS 160 and LC215 Coolipo, New Star Lasers, Inc. (2008) Summary page 1.

## Most influential descendants
- K151890: Medical Diode Laser Systems (2015), 3 descendants of its own
- K252063: Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (2025), 0 descendants of its own
- K243141: Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) (2024), 0 descendants of its own
- K191349: 980nm Diode Laser Therapy Device (2019), 0 descendants of its own
- K173067: LightForce LTS Model 1000, 1500, 2500, and 4000 (2018), 0 descendants of its own

## Recalls of this device
- Jan 4, 2013 · Class II · Z-0005-2014: Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.

## 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 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: Gastroenteroloay 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). Continued from previous page: Neurosurgery The hemostasis, 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, 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, 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; Continued from previous page: - 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 tumors; - excision, vaporization & hemostasis of rectal pathology; - pilondial cystectomy; - hemiorrhaphy; - 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. Continued from previous page: 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 (TUlIP); - 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. - 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; - adhesiolysis; - pericardiectomy - mediastinal and thoracic lesions and abnormalities; - mediastinal lymph node dissection; - thoracotomy. Continued from previous page: 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; - menorrhagia (810 nm or 980 nm only). - Open - conization of the cervix, including cervical intraepithelial neoplasia (GIN), 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. Continued from previous page: Pulmonology The, hemostasis, ablation, vaporization, excision, incision, 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. Continued from previous page: 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; - hemi glossectomy; Head & Neck - tumor resection on oral, subfacial and neck tissues; - parathyroidectomy; - thyroidectomy. Laser Assisted Lipolysis (980 nm only)

Source page: https://510kreport.com/device/K082721
Methodology: https://510kreport.com/methodology