(79 days)
K 875338
Not Found
No
The document describes a standard CO2 laser system for surgical applications and does not mention any AI or ML components or functionalities.
No
The device is described as a CO2 Laser used for soft tissue cutting and ablation in various surgical specialties, and for cutting and coagulation during surgery. These functions are primarily surgical tools, not typically categorized as therapeutic applications in a rehabilitative or healing sense.
No
The device description clearly states its purpose is for "soft tissue cutting and tissue ablation" and "cutting and coagulation at a wound during surgery," indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it is a physical laser console made of aluminum and optics, emitting laser light, and used with a handpiece or scalpel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft tissue cutting and tissue ablation" in various surgical specialties. This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The description details a CO2 laser system that emits laser light for "cutting and coagulation at a wound during surgery." This is a physical interaction with tissue, not an in vitro test.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with specimens.
Therefore, the CO2 Laser, Model C-LAS is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CO2 Laser, Model C-LAS is intended to be used by physicians for soft tissue cutting and tissue ablation in the following specialties:
- Cosmetic Surgery .
- Dermatology .
- General Surgery .
- Gynecology .
- Head & Neck Surgery .
- Neurosurgery .
- Oral Surgery .
- Orthopedic Surgery ●
- Otorhinolaryngology t
- Pediatric Surgery ●
- Plastic & Reconstructive Surgery t
- Podiatry
- Urology
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The CO2 Laser System, Model C-LAS is an easily transported table top laser console made of mainly machined aluminum and optics for the transmission of reflection of CO2 laser wave lengths. It is a carbon dioxide laser which emits laser light at 10.6 micrometers and has a RF excited laser tube which produces an output power of about 30 watts. The laser is for used by physicians for cutting and coagulation at a wound during surgery. The physician uses the laser light on tissue via lenses and a focusing hand piece, or via a diamond scalpel which transmits the laser light onto the scalpel.
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
Physicians
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.
K 875338
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
Image /page/0/Picture/0 description: The image shows the logo for Certified Software Solutions, Inc. The logo consists of the letters "CSS" in a bold, stylized font. The letters are black and have a horizontal line design. Below the letters, the words "Certified Software Solutions, Inc." are written in a smaller, sans-serif font.
MAR 0 2 2007
510(k) Summary
| Submitter/Applicant Name: | Clinicon Corporation |
|---|---|
| Contact: | Fritz Brauer |
| Address: | 3025-A Industry Street |
| Oceanside, CA 92054 | |
| Phone number: | (760) 439-1700 |
| Fax number: | (760) 439-1798 |
| Contact person: | Kim L. Bloom (CSS, Inc.) |
| Phone number: | (858) 675-8200 |
| Fax number: | (858) 675-8201 |
| Date prepared: | December 11, 2006 |
| Trade name: | C_Las CO2 Laser System |
| Common name: | CO2 Laser System |
| Classification name: | II |
Substantial equivalence claimed to:
K 875338: CHRYS (20 Watt CO2 Laser, cleared on April 13, 1988. The CHRYS (20 Watt CO2 Laser was cleared as a laser surgical instrument for use in general surgery as well as plastic surgery and in dermatology.
Device Description
The CO2 Laser System, Model C-LAS is an easily transported table top laser console made of mainly machined aluminum and optics for the transmission of reflection of CO2 laser wave lengths. It is a carbon dioxide laser which emits laser light at 10.6 micrometers and has a RF excited laser tube which produces an output power of about 30 watts. The laser is for used by physicians for cutting and coagulation at a wound during surgery. The physician uses the laser light on tissue via lenses and a focusing hand piece, or via a diamond scalpel which transmits the laser light onto the scalpel.
1
Intended Use
The CO2 Laser, Model C-LAS is intended to be used by physicians for soft tissue cutting and tissue ablation in the following specialties:
- Cosmetic Surgery .
- Dermatology .
- General Surgery .
- Gynecology .
- Head & Neck Surgery .
- Neurosurgery .
- Oral Surgery .
- Orthopedic Surgery .
- Otorhinolaryngology .
- Pediatric Surgery .
- Plastic & Reconstructive Surgery .
- Podiatry .
- Urology .
2
General Product Information
-
- Product Names: A.R.C. CO2 Laser System
-
- Regulatory Information
- Regulatory Section: 878.4810 a.
- Classification: Class II b.
- Product Code: GEX c.
- d. Panel: General & Plastic Surgery
-
- Intended Use:
- Indication(s) for use: Please see page 9 and 12. a.
- b. Special conditions for use statement(s): N/A
- Special instrument requirements: N/A c.
-
- Device Description: Please see 510k Summary page 8.
-
- Standard/Guidance Document Referenced: Please see pages 20
- Performance Characteristics: Please see the Software Test Procedures and Test 6. Report.
-
- System description: Please see the Operational's Manual.
- Product Safety Standards and Test Results: Please see Certificate of Conformity 8. attachment and Software Test Procedures.
Supporting specifications:
Please see attached validation documents (some of which may also be noted on the last page of this document):
-
- Certificate of Conformity
-
- Safety Risk Analysis
-
- Software Requirements Specification
-
- Software Test Procedures
-
- Software Test Report
-
- C-Las Brochure
-
- C-Las Operator's Manual
3
Technological Similarities and Differences to Predicate
Substantial equivalence claimed to:
K875338: CHRYS™ MODEL MED-MAX cleared on 04/13/1988 as a laser surgical instrument for use in general surgery as well as plastic surgery and in dermatology.
Summary of technological characteristics:
The following table describes similarities between CO2 Laser, Model C-LAS and the California Laboratories CHRYSTM MODEL MED-MAX (the predicate).
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Name | CO2 Laser, Model C-LAS | CHRYSTM MODEL MED- |
| MAX by California | ||
| Laboratories (K875338) | ||
| Intended use | Intended to be used by | |
| physicians to cut and | ||
| coagulate wounds during | ||
| surgery. | Intended to be used by | |
| physicians to cut and | ||
| coagulate wounds during | ||
| surgery. | ||
| Footprint | Compact | |
| 12.5"x 13" | Compact | |
| 15" by 20" | ||
| Laser | CO2 sealed | CO2 sealed |
| WaveLength | 10.6 micrometers | 10.6 micrometers |
| Mode | Continuous wave form | |
| (Gauss) | Continuous wave form | |
| (TEM00) | ||
| Accessories | Flexible Cable Waveguide | Articulated Arm |
| Waveguide | ||
| Output Power | About 30 Watts | About 30 Watts |
| Weight | 39.6 pounds | 45 pounds |
| Console | Microprocessor | Microprocessor |
| Laser Operation | Footswitch | Footswitch |
Based on the intended use and the use of laser technology for cutting and coagulation of wounds during surgery using a waveguide, the CO2 Laser is substantially equivalent to the California Laboratories CHRYS.
000011
4
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Clinicon Corporation % Certified Software Solutions, Inc. Ms. Kim L. Bloom Sr. Software Quality Engineer 16787 Bernardo Center drive, Suite A-1 San Diego, California 92128
MAR 0 2 2007
Re: K063698 Trade/Device Name: CO2 Laser, Model C-LAS 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: February 14, 2007 Received: February 15, 2007
Dear Ms. Bloom:
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 reclassifial 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
5
Page 2 - Ms. Kim L. Bloom
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
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), please contact the Office 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
(To be determined) 510(k) Number: Device Name: C Las CO2 Laser System
Indications for Use: The CO2 Laser, Model C-LAS is intended to be used by physicians for soft tissue cutting and tissue ablation in the following specialties:
- Cosmetic Surgery .
- Dermatology .
- General Surgery .
- Gynecology .
- Head & Neck Surgery .
- Neurosurgery .
- Oral Surgery .
- Orthopedic Surgery ●
- Otorhinolaryngology t
- Pediatric Surgery ●
- Plastic & Reconstructive Surgery t
- Podiatry
- Urology
Prescription Use
(Per 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of General. Restorative, and Neurological Devices |
| 510(k) Number | L063968 |
|---|---|
| --------------- | --------- |
| 000012 | |
|---|---|
| Page 12 of 20 |