# K091323: Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)

- Pathway: 510(k) (Special)
- Applicant: Intermedic Arfran, SA
- Decided: Jun 4, 2009 after 30 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: 17 generations back to K943450 (1995). 168 ancestors in all.
No later device cites it as a predicate yet.
0 of 169 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene, Intermedic Arfran, SA (2006) Summary page 1.
- K083682: 180W Cerelas D 980NM Diode Laser, Model D180, Biolitec, Inc. (2009) Summary page 1.

## Indications for use
The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is 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 980 nm Urology: -. Lesions of external genitalia * Circumcision * Condyloma * Bladder tumors * Bladder neck incisions * Vaporization of the prostate. Laser 980 nm General Surgery: * Rectal and anal hemorrhoidectomy • Mastectomy * Dermabrasion * Appendectomy (open and laparoscopic) * Bowel resection (open and laparoscopic) * Colectomy * Liver resection * Resections of organs * Thyriodectomy * Adhesiolysis * Hepatobiliary tumors * Throacotomy * Cholecystectomy (open and laparoscopic) * Condyloma * Breast biopsy Neurosurgery: * Percutaneous Disc Decompression * Discectomy * Hemostasis in conjunction with meningiomas Laser 980 nm 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 varicies · Excision of polyps Arthroscopy: * Chondromalacia * Synovectomy * Menisectomy Laser 980 nm Thoracic Surgery: * Thoracotomy * Pulmonary resection * Hemostasis * Pericardiectomy * Adhesiolysis · Coagulation of blebs and bullae Pulmonology: - Endoscopic pulmonary applications ; Tracheal bronchial lesions *Benign and 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 Laser 980 nm 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 telangiectasis, veinulectasisas 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, venus lakes, Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi. Laser 980 nm Dermatology/ Aesthetics: Continued * Dermatological surgery: Chondyloma acuminate, warts, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcoma. Warty leucoplasy and ulcers debridement. * Seborrheic keratoses · Mixoid cyst * Papillary varix * Acne treatment · Hair removal of unwanted hair from skin types 1-V Plastic Surgery: * Cut, coagulation & vaporization * Resurfacing * Blepharoplasty Vascular Surgery: · Endoluminal or endovenous laser surgery for saphenous incompetent veins

Source page: https://510kreport.com/device/K091323
Methodology: https://510kreport.com/methodology