# K020072: Athos Laser

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Apr 9, 2002 after 90 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: 1 generation back to K001704 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001704: ATHOS, Cosmos Medical Technology (2000) Summary page 3.

## Indications for use
The Athos laser is intended for hair removal (destruction of hair follicles) in all skin types and for soft tissue applications. The soft tissue applications are for the coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissues including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Dermatology: In addition to the tissue types cited, pigmented lesions to reduce lesion size; for patients with lesions that would potentially benefit from aggressive treatment; for patients with lesions that have not responded to other laser treatments. Endoscopic/Laparoscopic General Surgery: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in endoscopic, laparoscopic surgery applications, including but not limited to cholecystectomy, appendectomy, vagotomy, and pyloromyotomy. Gastroenterology: Tissue ablation and hemostasis in the GI tract; esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; GI hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers gastric erosions GI tissue ablation -including benign and malignant neoplasms, angiodysplasia; polyps, ulcer, colitis, and hemorrhoids. General Surgery: Soft tissue in general surgery applications, skin incisions, tissue-dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation. Gynecology: Treatment of menorrhagia by photocoagulation of thee endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excision procedures such as conization of the cervix, intra-uterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, uterine septum. Head and Neck/Otorhinolaryngology (ENT): Coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissue. Hemostasis during surgery: Adjunctive coagulation and hemostasis (control of bleeding) during surgery (endoscopic, laparoscopic, and open procedures). Neurosurgery: Hemostasis of pituitary tumor, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma. Oculoplastics: Incision, excision, vaporization, ablation, and coagulation of soft tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation of the eyeball, exteneration of orbital contents. Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications. Plastic Surgery: Incision, excision, cutting, coagulation, and vaporization soft tissue. Pulmonary/Thoracic Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures. Thoracic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue, including lung tissue, in thoracic applications including but not limited to isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets. Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma accuminata).

Source page: https://510kreport.com/device/K020072
Methodology: https://510kreport.com/methodology