MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE by DORNIER MEDTECH AMERICA, INC.

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, 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.

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and for use in the treatment of incompetence and reflux of superficial veins in the lower extremity.

The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, 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 28-85 cc.

Device Description

The Dornier Medilas D Family Lasers are continuous-wave diode laser emitting laser radiation in the invisible range of 940 nm. Each is calibrated during the manufacturing process and during service calls. The end-user does not calibrate fibers for this system. The Medilas D Family Lasers incorporate a graphic display panel, which shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas D Family Lasers feature several operating modes, including Standard, Fibertom, LITT and LPS. The lasers can be used in contact or non-contact open surgery with or without handpieces.

AI/ML Overview

This submission describes the Dornier Medilas D Family Lasers. The provided text indicates that the device's performance was evaluated against technological characteristics and overall performance, rather than specific quantitative acceptance criteria or a clinical study demonstrating statistically significant improvements.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
No significant differences existing between the proposed diode lasers and the predicate devices (Diomed D15 plus and D30 plus)	Dornier MedTech America, Inc. believes that no significant differences exist and that minor differences should not raise concerns regarding overall safety or effectiveness.
Compliance with Class IV performance standards for light-emitting products (promulgated under the Radiation Control for Health and Safety Act of 1968)	The Dornier Medilas D Family Lasers are in compliance with 21 C.F.R. §1040.10 and §1040.11.
Compliance with applicable voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE).	The lasers also comply with these standards.
Substantial Equivalence for Safety and Effectiveness (compared to predicate devices)	Dornier MedTech America, Inc. believes the devices are substantially equivalent, and differences are minor, not raising new issues of safety or effectiveness.

Study Information

The provided text does not describe a clinical study with a test set, ground truth, or expert review for the device's performance in its intended clinical applications. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and compliance with regulatory and voluntary standards.

Here's what can be inferred or stated as absent based on your questions:

Sample size used for the test set and the data provenance: Not applicable. No clinical test set described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth established by experts is mentioned for device performance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (laser system), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission revolves around compliance with engineering and safety standards, and technological similarity to predicate devices, rather than clinical outcomes verified by independent means.
The sample size for the training set: Not applicable. This device is a laser system, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary is for a medical laser system and focuses on demonstrating substantial equivalence to predicate devices through a review of technological characteristics and compliance with established safety and performance standards. It does not contain information about a clinical study involving a test set, ground truth, or expert review in the manner typically associated with submissions for diagnostic or AI-driven devices.

Summary

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This 510(k) summary of safety and effectiveness information is being submitted in This of the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

Submitter Name andAddress:	Dornier MedTech America, Inc.1155 Roberts Blvd.Kennesaw, GA 30144
Contact Person:	Theron GoberQuality and Regulatory Manager
Phone Number:	770-514-6204
Fax Number:	770-514-6288	JAN 30 2009
EstablishmentRegistration Number:	1037955
Date Prepared:	October 31, 2008
Device Trade Name(s):	Medilas D Family Lasers, including:Medilas D Litebeam Medilas D Litebeam + Medilas D Urobeam Medilas D Multibeam Medilas D FlexiPulse Medilas D MagnaPulse
Device Common Name:	Diode Laser System
Classification Name:	GEX - Laser Instrument, Surgical Powered
Predicate Device(s):	Diomed D15 plus an D30 plus
General DeviceDescription:	The Dornier Medilas D Family Lasers are continuous-wavediode laser emitting laser radiation in the invisible range of940 nm. Each is calibrated during the manufacturing processand during service calls. The end-user does not calibratefibers for this system. The Medilas D Family Lasersincorporate a graphic display panel, which shows laseroperating parameters, application modes, time functions,system status and messages for the user. The Medilas DFamily Lasers feature several operating modes, includingStandard, Fibertom, LITT and LPS. The lasers can be usedin contact or non-contact open surgery with or withouthandpieces.
Intended Use:	The Dornier Medilas D Family Lasers, specifically the Medilas

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D LiteBeam +. Medilas D Litebeam, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, 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,

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +. Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting. vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes. colonoscopies), in incision/excision. and a vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and for use in the treatment of incompetence and reflux of superficial veins in the lower extremity.

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Technological Characteristics:

Performance Data:

technological characteristics and overall performance of the devices, Dornier MedTech America, Inc. believes that no significant differences exist between the proposed diode lasers and the predicate devices. Dornier MedTech America, Inc. believes the minor differences

specifications, the Dornier Medilas D Family Lasers and the

predicate device are substantially equivalent. Based on the

From a clinical perspective and comparing design

of the Medilas D Family Lasers ant its predicates laser should not raise any concerns regarding the overall safety or effectiveness.

While no performance standards have been established for Diode lasers under Section 514 of the Federal Food, Drug, and Cosmetic Act, the Dornier Medilas D Family Lasers are in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control for Health and Safety Act of 1968. See 21 C.F.R. §1040.10 and §1040.11. The lasers also comply with the applicable requirements of the following voluntary standards: IEC 60601-1. IEC 60601-1-6. IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE).

Based on the technological characteristics and overall performance of the devices, Dornier MedTech America, Inc. believes that the Medilas D Family Lasers and the predicate device selected are substantially equivalent and that the differences between the devices are minor which do not raise new issues of safety or effectiveness.

Conclusion:

Dornier MedTech America, Inc. Medilas D Family Lasers 510(k) Submission October 31, 2008

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dornier MedTech America, Inc. % Mr. Theron Gober RA/OA Manager 1155 Roberts Boulevard Kennesaw, Georgia 30144

Re: K083258

Trade/Device Name: Medilas D Family Lasers Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and

JAN 3 0 2009

in dermatology Regulatory Class: II Product Code: GEX Dated: October 31, 2008 Received: November 4, 2008

Dear Mr. Gober:

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, Drugand 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. Iisting 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 may 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. Theron Gober

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Petmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)); please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Proprietary to Dornier MedTech America, Inc.

INDICATIONS FOR USE

KOP3258

510(k) Number (if known):

Device Name: Medilas D Family Lasers

Indications for Use

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, specialties: Pulmonary Surgery, Gastroenterology, ENT, and Radiology.

The Domier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and for use in the treatment of incompetence and reflux of superficial veins in the lower extremity.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	X
(Part 21 CFR 801 Subpart D)	AND/OR Over-The-Counter Use
	(Division (21 CFR 801 Subpart C))
	Division of General, Restorative,
	and Neurological Devices
510(k) Number	K083258

Dornier MedTech America, Inc.

Medilas D Family Lasers 510(k) Submission

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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.