(287 days)
Not Found
No
The description focuses on the physical characteristics and function of a CO2 laser for soft tissue surgery, with no mention of AI or ML.
No.
The device is described as a surgical laser for incision and excision of soft tissue, which falls under surgical not therapeutic use.
No
Explanation: The device description states its use is for "vaporization, incision and excision of soft tissue," which are surgical procedures, not diagnostic ones. It performs a therapeutic action rather than gathering information for diagnosis.
No
The device description clearly details a hardware-based surgical laser system with physical components like a handpiece made of stainless steel.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "vaporization, incision and excision of soft tissue" in various surgical specialties. This describes a surgical tool used directly on the patient's body for treatment.
- Device Description: The description details a surgical laser that delivers a beam of light to tissue. This is a physical intervention on the patient.
- Lack of IVD Characteristics: An IVD is used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
This device is a surgical laser, which is a therapeutic device used for treating patients directly.
N/A
Intended Use / Indications for Use
For use in vaporization, incision and excision of soft tissue in dermatology, general surgery, neurosurgery, oral surgery, oto-rhino-laryngology, and podiatry.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Clinicon C4 CO2 laser is a sealed, liquid and convection cooled carbon dioxide surgical laser that is DC excited. The output of the laser is a concentrated beam of invisible infrared light at 10.6 micrometer wavelength. The laser has an output power range of 0-25 watts delivered to tissue.
The laser system is fitted with a surgical hand piece as a standard accessory, producing a collimated beam with a spot size of 200 microns.
The hand piece is manufactured from 304 surgical stainless steel.
The Clinicon C CO2 laser is a sealed, liquid and convection cooled carbon dioxide surgical laser that is DC excited. The output of the laser is a concentrated beam of invisible infrared light at 10.6 micrometer wavelength. The laser has an output power range of 0-25 watts delivered to tissue.
The laser system is fitted with a surgical hand piece as a standard accessory, producing a collimated beam with a spot size of 200-microns. The hand-pieces sold with this device will be of the same design and configuration but will have various tip sizes and focal lengths.
These hand pieces are only intended for open surgery procedures in the non-contact mode.
The hand piece is manufactured from 304 surgical stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows a drawing of an oval shape that is overlaid on a grid. The grid appears to be 4 squares wide and 3 squares tall. There is a dark, shaded area inside the oval shape, and the number 4 is in the upper right corner of the image.
CLINICON CORPORATION CARLSBAD CALIFORNIA
OCT 2 9 1997
510(k) Summary
Submitter: Clinicon Coporation
Address: 2260 Rutherford Road Carlsbad, CA 92008
Phone number: 619-930-0010
Fax number: 619-930-0074
Contact person: Alan Bunting
Date prepared: January 9, 1997
Trade name: C4
Common name: Laser
Classification name: Class II
Substantial equivalence claimed to:
-
- Sharplan 20C K963229
-
- JMED CHRYS K913606
-
- Surgical Laser Specialties Ultra MD Laser 510k Number Unknown
Description:
The Clinicon C4 CO2 laser is a sealed, liquid and convection cooled carbon dioxide surgical laser that is DC excited. The output of the laser is a concentrated beam of invisible infrared light at 10.6 micrometer wavelength. The laser has an output power range of 0-25 watts delivered to tissue.
The laser system is fitted with a surgical hand piece as a standard accessory, producing a collimated beam with a spot size of 200 microns.
The hand piece is manufactured from 304 surgical stainless steel.
1
Intended use:
For use in vaporization, incision and excision of soft tissue in dermatology, general surgery, neurosurgery, oral surgery, oto-rhino-laryngology, and podiatry.
Summary of technological characteristics:
The Clinicon C4 CO2 Surgical Laser energy is delivered to the surgical site via an articulated arm. The substantially equivalent devices are delivered either by an articulated arm or a hollow flexible waveguide.
The Clinicon C4 CO2 Surgical Laser's surgical beam wavelength is in the (invisible) infrared region of the spectrum, at 10.6 micrometers (microns). The substantial equivalent devices are 10.6 micron wavelength.
Handpieces
HANDPIECE K 50R Surgical Handpiece straight. Focal length 2" Surgical handpiece straight. HANDPIECE K 100R Focal length 4" HANDPIECE K 100RO Surgical handpiece straight. Focal length 4" (OPEN CANNULA) Surgical Handpiece Angled. HANDPIECE K 100A Focal length 4" HANDPIECE K 100B Surgical Handpiece with backstop. Focal length 4" Surgical handpiece with backstop. HANDPIECE K 125B Focal length 5"
Manipulator
MICROMANIPULATOR KM Ring adapters available for most popular colposcopes and microscopes. MICROMANIPULATOR KMC Ring adapters available for most popular colposcopes and microscopes (Central mirror)
ﯿ
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1997
Mr. Fritz A. Brauer President Clinicon Corporation 2260 Rutherford Road Carlsbad. California 92008
Re: K970143 Trade Name: C4 CO2 Laser Regulatory Class: II Product Code: GEX Dated: August 13, 1997
Received: August 18, 1997
Dear Mr. Brauer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Fritz A. Brauer
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: C4 CO2 laser
Aug 18 12 43 PM '97
Indications for Use:
For use in vaporization, incision and excision of soft tissue in dermatology, general surgery, neurosurgery, oral surgery, oto-rhino-laryngology, and podiatry.
The Clinicon C CO2 laser is a sealed, liquid and convection cooled carbon dioxide surgical laser that is DC excited. The output of the laser is a concentrated beam of invisible infrared light at 10.6 micrometer wavelength. The laser has an output power range of 0-25 watts delivered to tissue.
The laser system is fitted with a surgical hand piece as a standard accessory, producing a collimated beam with a spot size of 200-microns. The hand-pieces sold with this device will be of the same design and configuration but will have various tip sizes and focal lengths.
These hand pieces are only intended for open surgery procedures in the non-contact mode.
The hand piece is manufactured from 304 surgical stainless steel.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K970143 |
| Prescription Use | X |
|---|---|
| OR | Over-the-Counter Use ______ |