DORNIER MEDILAS R

K984349 · Dornier · GEX · Feb 4, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K984349
• Device Name: DORNIER MEDILAS R
• Applicant: Dornier
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Dornier Medilas R Laser is intended to be used in a non-contact technical medical therapy unit, which is indicated for the dermatological application of epilation. The Medilas R is suitable for the following applications: General Surgery, Plastic Surgery, Cosmetology and Dermatology.

Device Story

The Medilas R is a long-pulse ruby laser system used for dermatological epilation. It functions as a non-contact medical therapy unit. Operated by clinicians in surgical, plastic surgery, cosmetology, or dermatology settings, the device delivers laser energy to the skin. The system is intended for professional use under prescription. It serves as a tool for hair removal, leveraging established laser technology similar to predicate ruby laser systems. The device provides clinical utility by enabling controlled laser-based epilation procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparisons to predicate devices.

Technological Characteristics

Long-pulse ruby laser system; non-contact delivery; intended for dermatological epilation. Class II device (Product Code GEX).

Indications for Use

Indicated for dermatological epilation in patients undergoing general surgery, plastic surgery, cosmetology, or dermatology procedures.

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

• Dornier Medilas H Laser System (K981718)
• Dornier Medilas E Laser System (K981438)
• Mehl/Biophile Chromos 694 (K962109)
• Sharplan EpiTouch Laser System (K972099)

Submission Summary (Full Text)

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# K984349

#### 510(k) SUMMARY Dornier Surgical Products, Inc's Medilas R Laser

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Walter Payerl President 1155 Roberts Boulevard Kennesaw, GA 30144 [phone] Phone: [phone] Facsimile:

Carol Wernecke Contact Person: Director of Regulatory and Clinical Affairs 1155 Roberts Boulevard Kennesaw, GA 30144

Date Prepared: January 18, 1999

## Name of Device and Name/Address of Sponsor

Medilas R Laser

Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw, GA 30144

#### Classification Name

FDA has not specifically classified Long Pulse Ruby lasers.

#### Predicate Devices

Dornier Medilas H Laser System Dornier Medilas E Laser System Mehl/Biophile Chromos 694 Sharplan EpiTouch Laser System

#### Intended Use

The Dornier Medilas R Laser is intended to be used in a non-contact technical medical therapy unit, which is indicated for the dermatological application of The Medilas R is suitable for the following applications: General epilation. Surgery, Plastic Surgery, Cosmetology and Dermatology.

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# Technological Characteristics and Substantial Equivalence

From a clinical perspective and comparing design specifications, the Dornier Medilas R Laser and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the devices. Dornier Surgical Products. Inc. believes that no significant differences exist between the Dornier Medilas R and the predicate devices: the Dornier Medilas H (K981718), Medilas E (K981438),Mehl/Biophile Chromos 694 (K962109) and Sharplan EpiTouch (K972099).

Dornier Surgical Products, Inc believes the minor differences of the Dornier Medilas R and its predicate laser devices should not raise any concerns regarding the overall safety or effectiveness.

# Advisory:

This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services-USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1999 FEB

Mr. Walter Payerl President Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw, Georgia 30144

Re: K984349 Trade Name: Dornier Medilas R Laser Regulatory Class: II Product Code: GEX Dated: December 2, 1998 Received: December 4, 1998

Dear Mr. Payerl:

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.

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Page 2 – Mr. Walter Payerl

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,

Stpt Rurbe

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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# Dornier Surgical Products, Inc.'s Medilas R Laser

# INDICATIONS FOR USE STATEMENT

| 510(K) Number: | K984349 |
|----------------|---------|
|----------------|---------|

Dornier Medilas R Laser ______________________________________________________________________________________________________________________________________________________ Device Name:

#### Indication For Use:

The Dornier Medilas R Laser is intended to be used in a non-contact technical medical therapy unit, which is indicated for the dermatological application of epilation. The Medilas R is suitable for the following applications: General Surgery, Plastic Surgery, Cosmetology and Dermatology.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-the-Counter Use | |
|------------------|---|----|----------------------|--|
|------------------|---|----|----------------------|--|

| (Division Sign-Off) | <img alt="Signature" src="signature.png"/> |
|-----------------------------------------|--------------------------------------------|
| Division of General Restorative Devices | |
| 510(k) Number | K984349 |

510(k) Number ________________________________________________________________________________________________________________________________________________________________