MULTIPULSE CO2 LASER

K983215 · Aesculap-Meditec GmbH · GEX · Dec 4, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K983215
• Device Name: MULTIPULSE CO2 LASER
• Applicant: Aesculap-Meditec GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesculap-Meditec CO2 Laser is intended for the ablation, vaporization, incision, excision, or cutting of soft tissue in oral surgery, E.N.T., gynecology, and dermatology. Aesculap-Meditec proposes that the MultiPulse CO2 laser be limited to prescription use.

Device Story

The Aesculap-Meditec MultiPulse CO2 laser emits a coherent light beam at 10.6 microns for soft tissue surgery. Used by surgeons in oral, E.N.T., gynecological, and dermatological procedures; device facilitates tissue ablation, vaporization, incision, and excision. Clinical applications include skin tumor removal, resurfacing, blepharoplasty, and laryngeal/pharyngeal tumor surgery. Device operates via laser energy delivery to target tissue; provider controls laser application to achieve desired surgical outcome. Benefits include precise tissue management during surgical interventions.

Clinical Evidence

Bench testing only. No clinical data provided; substantial equivalence established through comparison of specifications and indications for use to the predicate device.

Technological Characteristics

CO2 laser surgical instrument; emits coherent light at 10.6 microns. Classification: 21 CFR 878.4810, Product Code GEX. Device is a laser-based surgical system for soft tissue applications.

Indications for Use

Indicated for soft tissue ablation, vaporization, incision, excision, or cutting in oral surgery, E.N.T., gynecology, and dermatology. Contraindicated for patients whose tissue problems are caused by being overweight or drinking problems. Patients should be advised of potential post-operative vocalization issues.

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

• M.L.T. 30 (Medical Laser Technology, Inc.)

Submission Summary (Full Text)

{0}------------------------------------------------

#### APPENDIX E

# 510(k) SUMMARY AESCULAP-MEDITEC MULTIPULSE CO, LASER

<983215

This 510(k) summary of safety and effectiveness for the MultiPulse CO2 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: Aesculap-Meditec
- Address: 2525 McGaw Avenue Irvine, CA 92623-9791
- Manufacturer: Aesculap-Meditec-GmbH Prussingstrasse 41 D-07745 Jena Germany (011) +49/3641/653223 (011) +49/3641/652121
- Contact Person: Mr. William T. Kelley
- Telephone: [phone] (Fax)
- September 1998 Preparation Date: (of the Summary)
- MultiPulse CO2 laser Device Name:

Common Name: CO2 Laser

- Classification Laser surgical instrument for use in general and plastic surgery and in Name: dermatology (see: 21 CFR 8-78.4810). Product Code: GEX. Panel: 79
Legally marketed Medical Laser Technology-Inc. M.L.T. 30 predicate device:

Device description: The Aesculap-Meditec MultiPulse-CO2 laser emits a beam of coherent light at 10.6 microns.

{1}------------------------------------------------

The Aesculap-Meditec CO2 Laser is intended for the ablation, vaporization, Indications for: incision, excision, or cutting of soft tissue in oral surgery, E.N.T., gynecology, use: and dermatology.

The specifications of and indications for the Aesculap-Meditec MultiPulse CO2 Comparison to predicate device: laser are the same as or very similar to those of the claimed predicate, the M.L.T. 30 marketed by Medical Laser Technology, Inc.

- Performance Data: None. The specifications and indications for use of the Aesculap-Meditec MultiPulse CO2 laser are the same or very similar to those of the claimed predicate device.
Because of this, performance data were not required:

CONCLUSION: Based on the similarities of specifications and indications for use, Aesculap-Meditec believes that the MultiPulse CO, laser described in this notification is substantially equivalent to the cited legally marketed predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1998 DEC

Mr. William T. Kelley General Manager Aesculap-Meditec 2525 McGaw Avenue Irvine, California 92623-9791

Re: K983215 Trade Name: Multipulse CO2 Laser Regulatory Class: II Product Code: GEX Dated: September 9, 1998 Received: September 14, 1998

Dear Mr. Kelley:

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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.

{3}------------------------------------------------

### Page 2 - Mr. William T. Kelley

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 [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/dsmamain.html".

Sincerely yours,

piweef

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

{4}------------------------------------------------

## APPENDIX B rev. 10/98

#### INDICATIONS FOR USE STATEMENT

510(K) Number (if known): _ K983215 Device Name: Aesculap-Meditec MultiPulse CO2 laser

Indications For Use Statement:

The Aescular-Mediter CO2 laser is intended for the ablation, vaporization, incision, excision, and or cutting of soft tissue in:

| Oral surgery<br>Dermatology | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Examples: | Removal of small skin tumors, superficial pigmented lesions, adeno-<br>sebaceous hypertrophy, treatment of scars, skin tags, etc.<br>Skin resurfacing (scanning mode)<br>Blepharoplasty |
| E.N.T. | |
| Examples: | Tumor surgery of the larynx and pharynx<br>LAUP<br>Stenosis |
| CAUTION: | Patients should be diagnosed with tissue problems to exclude those<br>whose problems are caused by being overweight or to drinking<br>problems. |
| | Remind patients that there may be vocalization problems after laser<br>surgery. |

### Gynaecology

The examples are not intended to be exhaustive or complete but to serve as a general guide to the surgeon.

Aesculap-Meditec proposes that the MultiPulse CO2 laser be limited to prescription use. This labeling will be included in the final printing of the manual and on literature relating to the device.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OFFICE OF DEVICE EVALUATION)

| Prescription Use (Per 21 CFR 801.109) | <div style="text-align: left;">X</div> |
|---------------------------------------|----------------------------------------|
|---------------------------------------|----------------------------------------|

OR

| Over-The-Counter Use | ____________________ |
|----------------------|----------------------|
|----------------------|----------------------|

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K983215 |