# K110243: Medart Diode Laser System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Medart A/S
- Decided: Jun 28, 2011 after 152 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: 16 generations back to K943450 (1995). 185 ancestors in all.
No later device cites it as a predicate yet.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081015: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 4.

## Indications for use
The MedArt 720 Diode Laser System & Accessories is a prescription only device intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The MedArt 720 Diode Laser System & Accessories is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery and ophthalmology. The MedArt 720 Diode Laser System & Accessories is specifically indicated for laser assisted lipolysis Ear Nose, Throat & Oral Surgery: Hemnostasis, incision, excision, ablation, coagulation & vaporization of tissue from the ear, nose, throat & adjacent areas including soft tissue in the oral cavity. Dental Applications: Jntraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithclial lining of free gingiva Arthroscopy: Hemnostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery Gastroenterology: Hemostasis, incision, excision, ablation, coagulation & vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures General surgery, Dermatology, Plastic Surgery & Podiatry: Excision, ablation, vaporization and photocoagulation of skin lesions, hemnostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermnabrasion Urology: Excision, vaporization, incision, coagulation, ablation and hemnostasis of urological tissues Gynecology: Ablation, excision, incision, coagulation, hemnostasis and vaporization of gynecological tissue Neurosurgery: Vaporization, coagulation, excision, incision ablation and hemostasis of soft tissue Pulmonary Surgery: Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system Cardiothoraic Surgery: Incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue including cardiac tissues Laser Assisted Lipolysis: Laser Assisted Lipolysis Opthalmology: The ablation, vaporization, excision, incision, and coagulation of soft tissue in opthalmology

Source page: https://510kreport.com/device/K110243
Methodology: https://510kreport.com/methodology