# K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene - Pathway: 510(k) (Traditional) - Applicant: Intermedic Arfran, SA - Decided: Sep 6, 2006 after 260 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: 13 generations back to K943450 (1995). 160 ancestors in all. 299 later devices descend from it; 8 cite it directly. 0 of 460 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 7. - K040294: Laserpro Diode Laser Systems, Models 810, 940 & 980, Photo Medex, Inc. (2004) Summary page 7. - K031993: Aurora SR, Syneron Medical, Ltd. (2003) Summary page 7. - K050452: Aurora SR and Sra Applicator, Syneron Medical, Ltd. (2005) Summary page 7. - K052324: Polaris LV, Lva Applicator, Syneron Medical, Ltd. (2005) Summary page 7. - K041969: Aurora DS, Syneron Medical, Ltd. (2004) Summary page 7. - K041959: Polaris DS/Comet, Syneron Medical, Ltd. (2004) Summary page 7. - K050796: Aurora DS, DS Applicator, Syneron Medical, Ltd. (2005) Summary page 7. - K050824: 100W Ceralas D 980 Laser System, Model D100, Biolitec, Inc. (2005) Summary page 7. - K032864: Ceralas D 810 Diode Laser System, Model D15, Biolitec, Inc. (2004) Summary page 7. - K002296: Ceralas G15 532NM Frequency Doubled ND:Yag Laser, Model G1-G15, Ceram Optec, Inc. (2000) Summary page 7. - K021724: Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas D Skinpulse S Laser Systems, Dornier Medtech America, Inc. (2002) Summary page 7. - K000072: Dornier Medilas D Skinpulse, Dornier Surgical Products, Inc. (2000) Summary page 7. - K003993: Dornier Medilas D Skinpulse Laser System (Skinpulse), Dornier Surgical Products, Inc. (2001) Summary page 7. - K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System, Dornier Medtech America, Inc. (2002) Summary page 7. ## Most influential descendants - 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 - K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own ## Indications for use The INTERmedic Diode Laser Family (and their delivery accessories used to deliver optical, ultrasound and RF energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures. Examples include: » LASER 810nm and 980nm Urology: • Lesions of external genitalia • Circumcision • Condyloma • Bladder tumors • Bladder neck incisions • Vaporization of the prostate • Hepatobiliary tumors General Surgery: • Rectal an anal hemorrhoidectomy • Mastectomy • Dermabrasion • Appendectomy (open and laparoscopic) • Bowel resection (open and laparoscopic) • Colectomy • Liver resection • Resections of organs • Thyriodectomy • Adhesiolysis • Thoracotomy • Cholecystectomy (open and laparoscopic) • Condyloma • Breast biopsy Neurosurgery: • Percutaneous Disc Decompression • Discectomy • Hemostasis in conjunction with meningiomas Gynecology: • Cervical conization • Myomectomy • Endometrial ablation • Ovarian cystectomy • Appendectomy Ophthalmology: • Dacryocystorhinostomy transcanalicular • Open DCR • Tumor excision • Blepharoplasty Orthopedics: • Dissect and coagulate Gastroenterology: • Hemostasis of colonoscopy • Hemostasis of esophageal varices • Excision of polyps Arthroscopy: • Chondromalacia • Synovectomy • Menisectomy Thoracic Surgery: • Thoracotomy • Pulmonary resection • Hemostasis • Pericardiectomy • Adhesiolysis • Coagulation of blebs and bullae Pulmonology: • Endoscopic pulmonary applications • Tracheal bronchial lesions • Benign an malignant pulmonary obstruction Otolaryngology ENT: • Removal of benign lesions from the ear, nose and throat • Excision of carcinoma of the larynx • Incision and excision of carcinoma in situ • Neck dissection • Laryngeal papillomectomy • Removal of vocal cord/fold nodules, polyps and cysts Dental applications: • Frenectomy • Frenotomy • Biopsy • Pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening Pulmonary Surgery: • Endoscopic pulmonary applications • Tracheal bronchial lesions • Benign and malignant pulmonary or stricture Cardiac Surgery: • Coagulation and hemostasis of cardiac tissue Dermatology/Aesthetics: • Photocoagulation of vascular & dermatological lesions of the face and extremities • Photocoagulation of telangiectasia, veinulectasias of the legs and face • Treatment of reticular veins and branch varicosities • Pyogenic granuloma, lymphangioma and lymphagiomatosis disease, angiofibromas. • Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi. Dermatological surgery: Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasy and ulcers debridment. Seborrheic keratosis Mixoid cyst Papillary varix Acne treatment Hair removal of unwanted hair from skin type I-V Plastic Surgery: • Cut, coagulation & vaporization • Resurfacing non • Blepharoplasty Vascular Surgery: • Endoluminal or endovenous laser surgery for saphenous incompetent veins » ContrAge RF Dermatology/Aesthetics: Non invasive treatment of wrinkles and rhytids Non invasive scar reduction treatment (acne or traumatic scars) Source page: https://510kreport.com/device/K053540 Methodology: https://510kreport.com/methodology