DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM

K020339 · Dornier Medtech America, Inc. · GEX · Oct 25, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020339
• Device Name: DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM
• Applicant: Dornier Medtech America, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dornier MedTech America, Inc. is requesting the expansion of the indications for use for the Dornier Diode Laser family previously cleared under K982629, K000072. K003993 and K021724. The Dornier Diode Laser family. Medilas™ D Fibertom Laser ("Medilas D"), Medilas™ D SkinPulse™ ("SkinPulse") and Medilas™ D SkinPulse™ S ("SkinPulse S"), are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benion prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85cc and for cutting, vaporization, ablation, and coagulation of soft tissue in coniunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cvstoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without a handpiece). The SkinPulse™ and SkinPulse™ S lasers are also for use for the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair. The Dornier Diode Family Lasers are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology. This premarket notification requests clearance for the additional indication as stated: The Dornier diode family lasers, Medilas D Fibertom Laser ("Medilas D"), Medilas D SkinPulse ("SkinPulse") and Medilas D SkinPulse S ("SkinPulse S") are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Device Story

Dornier Diode Laser family (Medilas D, SkinPulse, SkinPulse S) delivers laser energy for surgical applications; used in urology, plastic surgery, general surgery, dermatology, gynecology, pulmonary surgery, gastroenterology, ENT, and radiology. Device functions via laser-tissue interaction for cutting, vaporization, ablation, and coagulation. Operated by physicians in clinical/surgical settings. Output allows for precise tissue management or endovascular vein coagulation. Benefits include minimally invasive treatment options for BPH, vascular lesions, hair removal, and venous reflux.

Clinical Evidence

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

Technological Characteristics

Diode laser system; 810 nm wavelength; used for soft tissue surgery and endovascular coagulation. System includes Medilas D, SkinPulse, and SkinPulse S models. Class II device (Product Code GEX).

Indications for Use

Indicated for men >50 with BPH (prostate volume 28-85cc) for urinary outflow obstruction; patients with superficial vein reflux for endovascular coagulation of greater saphenous vein; patients requiring soft tissue cutting, vaporization, ablation, or coagulation in endoscopic or open surgery; patients with vascular lesions or unwanted hair (SkinPulse/SkinPulse S 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

• Diomed 810 nm Surgical Lasers (K012398)
• Dornier Medilas D Laser System (K982629)
• Dornier Medilas D SkinPulse Laser System (K000072)
• Dornier Medilas D SkinPulse S Laser System (K003993)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Diode Laser Family

KD20339

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Dornier Diode Lasers is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device which includes the following: Diomed 810 nm Surgical Lasers as well as the Dornier diode lasers themselves, Dornier Medilas D Laser System (K982629), Dornier Medilas D SkinPulse Laser System (K000072) and Dornier Medilas D SkinPulse S Laser System (K003993).

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

| Dornier MedTech America, Inc. | Phone: | 770-514-6163 |
|-------------------------------|------------|---------------------------------|
| 1155 Roberts Boulevard | Facsimile: | 770-514-6288 |
| Kennesaw, GA 30144 | | |
| Contact Person: Tim Thomas | | Date Prepared: October 21, 200_ |

#### Name of Device and Name/Address of Sponsor

Dornier's Diode Laser Family, including:

- Medilas D Laser System ("Medilas D") .
- Medilas D SkinPulse Laser System ("SkinPulse") ●
- Medilas D SkinPulse S Laser System ("SkinPulse S") .

Dornier MedTech America, Inc. 1155 Roberts Boulevard Kennesaw, GA 30144

#### Classification Name

Diode lasers have not been specifically classified by FDA.

#### Predicate Devices

- > Diomed 810 nm Surgical Lasers (K012398)
- A Dornier Medilas D Laser System (K982629)
- Dornier Medilas D SkinPulse Laser System (K000072) A
- > Dornier Medilas D SkinPulse S Laser System (K003993)

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### Intended Use

Dornier MedTech America, Inc. is requesting the expansion of the indications for use for the Dornier Diode Laser family previously cleared under K982629, K000072. K003993 and K021724. The Dornier Diode Laser family. Medilas™ D Fibertom Laser ("Medilas D"), Medilas™ D SkinPulse™ ("SkinPulse") and Medilas™ D SkinPulse™ S ("SkinPulse S"), are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benion prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85cc and for cutting, vaporization, ablation, and coagulation of soft tissue in coniunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cvstoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without a handpiece). The SkinPulse™ and SkinPulse™ S lasers are also for use for the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.

The Dornier Diode Family Lasers are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology.

This premarket notification requests clearance for the additional indication as stated:

The Dornier diode family lasers, Medilas D Fibertom Laser ("Medilas D"), Medilas D SkinPulse ("SkinPulse") and Medilas D SkinPulse S ("SkinPulse S") are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

### Technological Characteristics and Substantial Equivalence

From a clinical perspective and comparing design specifications, the Dornier diode lasers and the predicate device, Diomed 810 nm Surgical Lasers are substantially equivalent. Based on the technological characteristics and overall performance of the devices, Dornier MedTech America, Inc. believes that no significant differences exist between the Dornier diode lasers and the predicate device.

Dornier believes the minor differences of the Dornier diode family lasers and its predicate laser devices should not raise any concerns regarding the overall safety or effectiveness.

Page 2 of 3

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- 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/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three profiles facing to the right, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 5 2002

Dornier Medtech America, Inc. Tim Thomas Director, Regulatory, Quality & Clinical 1155 Roberts Boulevard Kennesaw, Georgia 30144

Re: K020339

Trade/Device Name: Dornier Diode Laser Systems (Medilas D, Medilas D SkinPulse, Medilas D SkinPulse S) Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: August 21, 2002 Received: August 23, 2002

Dear Mr. Thomas:

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 reclassified 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. Ilsting 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 mav 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Tim Thomas

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

fel Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

510(k) Number: K020339

Device Name:

Dornier's Diode Laser Family

- Medilas D Fibertom Laser System .
- Medilas D SkinPulse Laser System .
- Medilas D SkinPulse S Laser System .

Indications for Use:

Dornier MedTech America, Inc. is requesting the expansion of the indications for use for the Dornier Diode Laser family previously cleared under K982629, K000072, K003993 and K021724. The Dornier Diode Laser family, Medilas™ D Fibertom Laser ("Medilas D"), Medilas™ D Skinulse™ ("SkinPulse") and Medilas™ S ("SkinPulse™ S ("SkinPulse S"), are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85cc and for cutting, vaporization, ablation, and coagulation of soft tissue in coniunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without a handpiece). The SkinPulse™ and SkinPulse™ S lasers are also for the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.

The Dornier Diode Family Lasers are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology,

This premarket notification requests clearance for the additional indication as stated:

The Dornier diode family lasers, Medilas D Fibertom Laser ("Medilas D"), Medilas D SkinPulse ("SkinPulse") and Medilas D SkinPulse S ("SkinPulse S") are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

| Prescription Use | |
|------------------|--|
|------------------|--|

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Miroam C. Profete-Counter Use |
|--|-----------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative and Neurological Devices |

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n20339