(28 days)
Not Found
No
The summary describes a standard CO2 surgical laser system with no mention of AI or ML components in the device description, intended use, or performance studies.
Yes
The device is indicated for surgical procedures like incision, excision, ablation, vaporization, and coagulation of soft tissues, which are therapeutic actions aimed at treating a medical condition or improving health.
No
The device is described as a surgical laser system intended for the "incision, excision, ablation, vaporization and coagulation of body soft tissues," which are therapeutic actions, not diagnostic ones.
No
The device description explicitly lists hardware components such as a power supply, cooling system, laser head, articulated arm, handpiece, microcomputer, and control panel, indicating it is a physical system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Azuryt Model CTL 1401 is a CO₂ Surgical Laser System. Its intended use is for the incision, excision, ablation, vaporization, and coagulation of body soft tissues directly on the patient. This is a surgical procedure performed in vivo (within the living body).
The description clearly indicates a surgical tool used for treating tissues directly, not for analyzing samples in a lab setting.
N/A
Intended Use / Indications for Use
The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues. These systems can be used in a variety of medical specialties, including general and plastic surgery, dentistry, oral/maxillofacial surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology, aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology.
Product codes
GEX
Device Description
The, Azuryt Model CTL 1401 CO₂ Surgical Laser System is a CO₂ laser consisting of a power supply, cooling system, laser head, articulated arm, handpiece, microcomputer and control panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues, intraoral tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K031224, K031440, K896478, K953074, K960475
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Premarket Notification [510(k)] Summary (per 21 CFR 807.92)
1. Submitted by:
Diamond Age Systems, Inc. 3775 South Laurel Way Chandler, AZ 85249 Phone: (866) 546-5444
Contact Person: Geoffrey D. Swank Vice-President of Laser Operations Phone: (303) 263-3307 Fax: (303) 985-7957
Date Prepared: 29 August 2004
2. Device Name
Trade/Proprietary Name: Common/Usual Name: Classification Name:
Azurvt Model CTL 1401. CO2 Surgical Laser System General Surgical Laser System Laser Instrument, Surgical, Powered (per 21 CFR 878.4810)
3. Predicate Device:
The Azuryt Model CTL 1401, CO2 Surgical Laser System is substantially equivalent to other laser systems on the market, such as the Deka Smart CO2 laser, cleared under K031224 and K031440; and the Lumenis LX-20 CO2 Surgical Laser System, cleared under K896478, K953074, and K960475.
4. Intended use of the device
The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coaqulation of body soft tissues, including intraoral tissues. These systems can be used in a variety of medical specialties, including general and plastic surgery, dentistry, oral/maxillofacial surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology, aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology.
1
Description of the Device 5.
The, Azuryt Model CTL 1401 CO₂ Surgical Laser System is a CO₂ laser consisting of a power supply, cooling system, laser head, articulated arm, handpiece, microcomputer and control panel.
Summary of the technological characteristics of the device 6. compared to the predicate device.
Like the predicate devices, the Azuryt Model CTL 1401 is a CO2 surgical laser system, utilizing a laser with a wavelength of 10.6 µm. Each of these devices contains a power supply, a cooling system, a sealed CO2 laser head delivering a beam with a wavelength of 10.6 um, an arm to deliver the laser beam, a handpiece and a variety of accessories to address specific surgical needs.
7. Testing
The manufacturer of the Azuryt Model CTL 1401certifies that its device complies with the following international standards:
EN60825-1. IEC 60825-1. Safety of laser products - Part 1: Equipment classification, requirements and user's guide.
EN60601-2-22, IEC 60601-2-22, Medical Electrical Equipment -- Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
EN60601-1. IEC 60601-1. Medical Electrical Equipment - Part 1: General requirements for safety, as amended by amendment 1 (1991) and amendment 2 (1995).
EN60601-1-2, IEC 60601-1-2, Medical Electrical Equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests
The device also complies with the European Medical Device Directive 92/42/EEC and the US Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products, except for deviations pursuant to Laser Notice No. 50, dated 26 July 2001.
8. Conclusions
Based upon the testing and comparison to the predicate devices, the Azuryt Model CTL 1401 has the same intended uses, with similar technological characteristics as the predicate devices. The system performs as intended and raises no new safety or effectiveness issues.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Diamond Age Systems, Inc. c/o Mr. Ned E. Devine Entela. Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K042439
Trade/Device Name: Azuryt Model CTL 1401, CO2 Surgical Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 21, 2004 Received: September 22, 2004
0C1 7 - 2004
Dear Mr. Devine:
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.
3
Page 2 - Mr. Ned Devine
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in your le FDA finding of substantial equivalence of your device to a legally promated nevice 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), please 11 you attire of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronal 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 vours,
Sincerely yours,
Mark A. Millerson
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
4
Indications for Use
510(k) Number (if known): K042439
Device Name: Azuryt Model CTL 1401, CO2 Surgical Laser System
Indications For Use:
The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues. These systems can be used in a variety of medical specialties, including general and plastic surgery, dentistry, oral/maxillofacial surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology, aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K042439
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