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.

Device Description

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") .

AI/ML Overview

This is a 510(k) summary for a medical device (Dornier Diode Laser Family), which focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance studies against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in the provided document.

Here's an breakdown of what can be extracted and what is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated. The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific quantifiable performance targets.
Reported Device Performance: Not explicitly stated in numerical terms against acceptance criteria. The document asserts "no significant differences exist between the Dornier diode lasers and the predicate device" based on "technological characteristics and overall performance."

Acceptance Criteria	Reported Device Performance
Not specified	Substantially equivalent to predicate devices (Diomed 810 nm Surgical Lasers, Dornier Medilas D Laser System, Dornier Medilas D SkinPulse Laser System, Dornier Medilas D SkinPulse S Laser System) in technological characteristics and overall performance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable / Not mentioned. This document does not describe a clinical study with a "test set" in the context of algorithm performance or diagnostic accuracy. It's a submission for laser device clearance based on substantial equivalence.
Data Provenance: Not applicable / Not mentioned. No specific patient data or study data is detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable / Not mentioned. No ground truth establishment processes for a test set are described as this is not a study assessing diagnostic performance.
Qualifications of Experts: Not applicable / Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable / Not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No. This document does not describe such a study.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. This device is a laser system, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable. The "ground truth" in this context is the safety and effectiveness of the predicate devices, to which the new device is compared. There's no clinical "ground truth" being established by experts for a specific diagnostic task.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable / Not mentioned. This is a medical device 510(k) submission, not an AI/algorithm development document.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable / Not mentioned.

Summary

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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.

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

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.
Image /page/2/Picture/3 description: The image shows the numbers 01 0:7. The numbers are written in a simple, sans-serif font. The numbers are arranged horizontally, with a space between each number. The numbers are all the same size and color.

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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 (301) 594-4659. Additionally, for questions on the promotion and advertising of vour 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 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 (800) 638-2041 or (301) 443-6597 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:

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

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

01 0.1

n20339

Regulation Number and Section

§ 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.