510(k) Report

510(k) · Cleared

Cleared

Athos Laser

K020072510(k) TraditionalCleared Apr 9, 200290-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Quantel Medical · GEX Powered Laser Surgical Instrument

Cleared on Apr 9, 2002 as substantially equivalent to K001704 (Cosmos Medical Technology, 2000) after a 90-day review. Its family tree reaches back 1 generation to 2000.

Decided
Apr 9, 2002
Review
90 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001704 (2000). No later device cites it as a predicate yet.

K001704 · ATHOS · Cosmos Medical Technology · 2000200020022004
K001704 · ATHOS · Cosmos Medical Technology · 20000
  1. Root · 1 generation backK001704 ATHOSCosmos Medical Technology · 2000
  2. This deviceK020072 Athos LaserQuantel Medical · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001704ATHOSCosmos Medical Technology2000—
0 (this device)K020072Athos LaserQuantel Medical2002—
FIG. 1 — Lineage of K020072, 2000–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

  1. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K001704ATHOS
Summary page 3
…in the notification Quantel Medical concludes that the Athos laser which is the subject of this notification is substantially equivalent to the Athos laser described in K001704 under the conditions of intended use. 023 { SERVIC; W 5! s, & SR, e, 2y %, “Uvgza (C DEPARTMENT OF HEALTH & H…
Cosmos Medical Technology2000—

Also cleared against K001704: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K001704.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

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…

Read the full statement (440 words)

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).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K020072: Athos Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020072

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026