COMPACT KTP LASER

K983020 · Cosmos Medical Technology · GEX · Nov 25, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K983020
• Device Name: COMPACT KTP LASER
• Applicant: Cosmos Medical Technology
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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).

Device Story

The COMPACT KTP laser is a frequency-doubled Nd:YAG laser emitting coherent light at 532 nm. It is used by surgeons for soft tissue procedures in dermatology, including coagulation, ablation, vaporization, incision, and excision. The device functions by delivering laser energy to target tissues; the clinician directs the beam to achieve the desired therapeutic effect. It is intended for prescription use in clinical settings.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Frequency-doubled Nd:YAG laser; emits coherent light at 532 nm. Standalone surgical instrument.

Indications for Use

Indicated for coagulation, ablation, vaporization, incision, excision, and cutting of soft tissue in dermatology, including benign vascular lesions (port wine stains, erythrosis, couperosis, facial telangiectasias, leg veins, micro-varicosities) and benign pigmented lesions (senile lentigo). Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Laserscope Aura Laser System
• American Laser Medical NovuLase 660 Laser System
• Laserscope KTP/532
• KTY/YAG-lasers

Submission Summary (Full Text)

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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<br>San Diego, CA 92198 |
| Manufacturer: | Crystal Focus, S.A.<br>19 Rue Ampere, BP 35<br>91302 Massy, France<br>(011) [phone]-<br>(011) [phone] (Fax) |
| Preparation Date:<br>(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<br>dermatology<br>21 CFR 878.4810).<br>Product Code: GEX.<br>Panel: 79 |
| Legally marketed<br>predicate device: | Laserscope Aura Laser System; American Laser Medical NovuLase 660<br>Laser System; and Laserscope KTP/532 and KTY/YAG-lasers,. |
| Device description: | The COSMOS Medical Technology COMPACT KTP laser emits a beam<br>of coherent light at 532 nanometers as do the predicate devices. |
| Indications for use: | The COSMOS Medical Technology COMPACT KTP laser is intended for<br>the coagulation, ablation, vaporization, incision, vaporization, incision,<br>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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#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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)