(86 days)
Laserscope Aura Laser System, American Laser Medical NovuLase 660 Laser System, Laserscope KTP/532 and KTY/YAG-lasers
Not Found
No
The summary describes a laser device for soft tissue treatment and does not mention any AI or ML components or functionalities.
Yes
The device's intended use is for the coagulation, ablation-vaporization, incision, excision, and/or cutting of soft tissue for the treatment of various dermatology conditions (e.g., Benign Vascular Lesions, Port Wine Stains, Benign Pigmented Lesions, Senile Lentigo), which are all therapeutic interventions.
No
Explanation: The device description states its intended uses are for "coagulation, ablation- vaporization, incision, excision, and/or cutting of soft tissue," which are surgical or therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "COMPACT KTP laser" which emits a beam of coherent light, 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 the "coagulation, ablation- vaporization, incision, excision, and/or cutting of soft tissue in dermatology." This describes a therapeutic or surgical procedure performed directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples.
- Device Description: The description focuses on the laser's function and wavelength, consistent with a surgical or therapeutic device.
- Lack of IVD-related information: There is no mention of analyzing samples, diagnostic results, or any of the typical components or processes associated with IVDs.
Therefore, the COMPACT KTP laser is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The COSMOS Medical Technology COMPACT KTP laser is intended for the coagulation, ablation, vaporization, incision, excision, or cutting of soft tissue in dermatology
Product codes
GEX
Device Description
The COSMOS Medical Technology COMPACT KTP laser emits a beam of coherent light at 532 nanometers as do the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue in dermatology
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)
The specifications and indications for use of the COSMOS Medical Technology COMPACT KTP laser are the same or very similar to those of the claimed predicate devices. Because of this, performance data were not required. COSMOS Medical Technology believes that the COMPACT KTP laser described in this notification is substantially equivalent to the cited legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Laserscope Aura Laser System; American Laser Medical NovuLase 660 Laser System; and Laserscope KTP/532 and KTY/YAG-lasers
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
983020
APPENDIX E
510(k) SUMMARY COSMOS MEDICAL TECHNOLOGY COMPACT KTP LASER
This 510(k) summary of-safety-and-effectiveness-for the-COSMOS Medical Technology COMPACT KTP 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.
| Applicant: | COSMOS-Medical Technology |
|---|---|
| Address: | P.O. Box 27210 |
| San Diego, CA 92198 | |
| Manufacturer: | Crystal Focus, S.A. |
| 19 Rue Ampere, BP 35 | |
| 91302 Massy, France | |
| (011) +33-1-6920-8454- | |
| (011) +33 1 6981 7639 (Fax) | |
| Preparation Date: | |
| (of the Summary) | August 1998 |
| Device Name: | COMPACT KTP laser |
| Common Name: | Frequency doubled Nd: YAG laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in |
| dermatology | |
| 21 CFR 878.4810). | |
| Product Code: GEX. | |
| Panel: 79 | |
| Legally marketed | |
| predicate device: | Laserscope Aura Laser System; American Laser Medical NovuLase 660 |
| Laser System; and Laserscope KTP/532 and KTY/YAG-lasers,. | |
| Device description: | The COSMOS Medical Technology COMPACT KTP laser emits a beam |
| of coherent light at 532 nanometers as do the predicate devices. | |
| Indications for use: | The COSMOS Medical Technology COMPACT KTP laser is intended for |
| the coagulation, ablation, vaporization, incision, vaporization, incision, | |
| excision, or cutting of soft tissue in dermatology |
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- Comparisons: The specifications of and indications for the -COSMOS Medical Technology COMPAET KTP laser are the same as or very similar to those of the claimed predicates. None. The specifications and indications for use of the COSMOS Performance Data: Medical Technology COMPACT KTP laser are the same or very similar to those of the claimed predicate devices. Because of this, performance data were not required. CONCEUSION: Based- on the similarities of specifications and-indications-for-use, COSMOS Medical Technology believes that the COMPACT KTP laser described in this notification is substantially equivalent to the cited legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three lines representing the body, head, and arm. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 25 1308
Mr. John P. Clark President COSMOS Medical Technology P.O. Box 27210 San Diego, California 92198
Re: K983020 Trade Name: COMPACT KTP Laser Regulatory Class: II Product Code: GEX Dated: August 27, 1998 Received: August 31, 1998
Dear Mr. Clark:
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 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). 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. John P. Clark
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 vour 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/dsma/dsmamain.html".
Sincerely yours,
toscello
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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APPENDIX B
INDICATIONS FOR USE STATEMENT
rg83020 510(K) Number (if known) : _
Device Name: COSMOS Medical Technology COMPACT KTP Laser
Indications For Use Statement:
The COMPACT-KTP-laser-is-intended-for-the-coagulation, ablation- vaporization, incision, excision, and/or cutting of soft tissue in dermatology.
Examples of applications include:
- Benign Vascular Lesions Port Wine Stains Erythrosis Couperosis Facial Telangiectasias Leg Veins - Micro-varicosities Benign Pigmented Lesions Senile Lentigo
- The examples are not intended to be exhaustive or complete but-to serve as a general guide to surgeons.
Labeling in the draft manual restricts the COMPACT KTP laser to prescription use (see page 13 of the draft manual - APPENDIX A).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109)
Concurrence of CDRH Office of Device Evaluation (ODE)