(90 days)
N/A
No
The summary describes a laser device for various surgical applications and hair removal. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The device description is purely about the laser's physical properties and intended uses.
Yes.
The device is intended for various medical and surgical applications to treat or alleviate diseases/conditions, which aligns with the definition of a therapeutic device.
No
The device is intended for therapeutic interventions such as hair removal, tissue coagulation, incision, excision, ablation, and vaporization, not for diagnosing conditions.
No
The device description explicitly states it is a "laser" which is a hardware component that emits light. The intended use also describes physical interactions with tissue (hair removal, coagulation, incision, etc.), which are performed by a hardware device.
Based on the provided information, the Athos laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of the Athos laser is for various surgical and dermatological procedures involving the direct interaction with and modification of soft tissues and hair follicles within the human body. This includes cutting, coagulation, ablation, vaporization, and hair removal.
- IVD Definition: An IVD device is defined as a medical device intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the body.
- Device Description: The device description confirms it's a laser emitting light at a specific wavelength, consistent with a surgical or therapeutic laser, not a device for analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, diagnostic information being provided, or any of the typical components or processes associated with IVD devices (e.g., reagents, assays, specimen handling).
The Athos laser is clearly intended for in vivo (within the living body) procedures, which is the opposite of the "in vitro" nature of IVD devices.
N/A
Intended Use / 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.
Tissue ablation and hemostasis in the GI tract; Gastroenterology: esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; GI hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, nonbleeding 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): For the 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 turnors, enucleation of the eyeball, exteneration of orbital contents.
Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intraarticular 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 turnors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma accuminata).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Athos laser emits a beam of coherent light at 1064 microns.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
All skin types; soft tissues including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands; pigmented lesions; GI tract; esophageal; uterus, endometrial lining of the uterus, endometrial implants, peritoneal adhesions, cervix; head and neck; pituitary, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma; lacrimal system, eyelids, orbital; intraarticular tissue; pulmonary airway; lung tissue; urinary bladder, urethral, external genitalia.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: None required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
SECTION 10
510(k) SUMMARY
K020072 113
This 510(k) summary of safety and effectiveness for the Athos Long Pulsed Nd:YAG laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
Quantel Medical Applicant:
QUANTEL MEDICAL Address: 21 rue Newton ZI du BREZET 63039 Clermont-Ferrand Cedex 2 FRANCE +33 (0)473 745 745 +33 (0)473 745 700 (Fax)
Mr. Jean Abascal Contact Person:
(+33) 169 29 17 25 (+33) 169 29 17 29
Preparation Date: December 2001 (of the Summary)
Athos laser Device Name:
Nd: YAG Surgical Laser (Long Pulse Nd: YAG laser) Common Name:
Laser surgical instrument for use in general and plastic surgery and in Classification dermatology (see: 21 CFR 878.4810). Name: Product Code: GEX Panel: 79 :
The Athos Long Pulse Nd:YAG laser Predicate device:
Device description: The Athos laser emits a beam of coherent light at 1064 microns.
The Athos laser is intended for hair removal (destruction of hair follicles) in Indications: all skin types and for soft tissue applications.
1
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.
Tissue ablation and hemostasis in the GI tract; Gastroenterology: esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; GI hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, nonbleeding 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.
Treatment of menorrhagia by photocoagulation of thee Gynecology: 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): For the 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.
2/3
2
K020072 3/3
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 turnors, enucleation of the eyeball, exteneration of orbital contents.
Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intraarticular 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 turnors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma accuminata).
The Athos laser will be labeled as a prescription device:
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
Performance Data: None required.
CONCLUSION:
Based on the information 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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, composed of three overlapping profiles facing to the right. The profiles are black, and the overall design is simple and modern. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 9 2002
Quantel Medical c/o Mr. Roger W. Barnes 342 Sunset Bay Road Hot Springs, AR 71913
Re: K020072
Trade/Device Name: Athos Laser Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 7, 2002 Received: January 9, 2002
Dear Mr. Barnes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 -- Mr. Roger W. Barnes
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K020072
Device Name: Athos laser (Nd: YAG Long-pulsed laser)
Indications for Use Statement:
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 and cutting, ablation, coagulation/hemostasis of soft tissue in endoscopic, laparoscopic surgery applications, including but not limited to cholecystectomy, appendectomy, vagotomy, and pyloromyotomy.
Tissue ablation and hemostasis in the GI tract; esophageal Gastroenterology: 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.
Continued on second page
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use 17 (Per 21 CFR 801.109) OR
Over-The Counter Use
Indications for Use Statement: (Continued)
6
K020072 2/3
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).
Hemostasis of pituitary tumor, meningioma, hemagioblastoma, Neurosurgery: AVMs. glioma, glioblastoma, astrocytoma, oligodendroglioma.
Incision, excision, vaporization, ablation, and coagulation of soft Oculoplastics: 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.
Palliative treatment of benign and malignant Pulmonary/Thoracic Surgery: 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).
The Athos laser will be labeled as a prescription device as follows:
7
K0200723/3
CAUTION: Federal (US) law restricts the use of this device to licensed.professionals
・
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________