MODIFICATION OF MLT R694 RUBY LASER SYSTEM by MEDICAL LASER TECHNOLOGIES LTD.

The MLT R694 Ruby Laser System (operating in the Q-Switched mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tatoo removal and treatment of benign pigmented lesions.

The MLT R694 Ruby Laser System is restricted to sale to or use by licensed professionals in the United States

Device Description

The MLT R694 laser operates as a normal pulse or as a O-Switched rubv laser which emits a beam of coherent light at 694 nanometers. In the Q-Switched mode the beam has a much shorter pulse duration than in the normal or long pulse mode. The specifications for the normal or long pulse mode remain the same as described in K980187.

AI/ML Overview

The provided document, a 510(k) summary for the MLT R694 Ruby Laser System, states that no performance data was required because "The specifications and intended uses of the MLT R694 ruby system laser operating in the Q-Switched mode are the same or very similar to those of the claimed predicate devices." Therefore, no specific acceptance criteria or studies proving the device meets them are detailed in this document.

The submission relies on substantial equivalence to predicate devices. This means that instead of conducting new performance studies, the manufacturer demonstrated that their device is as safe and effective as other legally marketed devices (predicates) with similar characteristics and intended uses.

Based on the provided text, the following information is not available or not applicable:

Table of acceptance criteria and reported device performance: Not applicable, as performance data was not required for this 510(k) submission.
Sample size used for the test set and the data provenance: Not applicable. No test set was used, as performance data was not required.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth was used.
Adjudication method for the test set: Not applicable. No test set was used.
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, and no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a laser system, not an algorithm.
The type of ground truth used: Not applicable. No test set requiring ground truth was used.
The sample size for the training set: Not applicable. This device is a laser system, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable. This device is a laser system, not an AI model.

Summary of available information regarding the justification for market clearance:

Basis for Clearance: Substantial Equivalence to legally marketed predicate devices.
Predicate Devices: LaseAway Long Pulse and Q-Switched Ruby Laser, MM-Ruby Laser; Spectrum RD 1200; Candela AlexLAZR.
Reason for no performance data: The specifications and intended uses of the MLT R694 ruby system laser operating in the Q-Switched mode are the same or very similar to those of the claimed predicate devices.
Conclusion: The MLT R694 in Q-Switched mode is substantially equivalent to legally marketed predicate devices. The normal mode operation of the MLT R694 (K980187) was already found substantially equivalent and its characteristics are not affected by the Q-Switched modification.

Summary

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510(k) SUMMARY MEDICAL LASER TECHNOLOGIES LTD MLT R694 RUBY LASER SYSTEM Q-SWITCHED MODE

This 510(k) summary of safety and effectiveness for the Medical Laser Technologies Ltd. MLT R694 Ruby Laser System operating in the O-Switched Mode 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.

MEDICAL LASER TECHNOLOGIES LTD Applicant:

Address: Unit 15 Belleknowes Industrial Estate Inverkeithing Fife KY11 1HZ United Kingdom
Contact Person: David Hamilton . Managing Director
Telephone: 011 44 1383 411555 011 44 1383 411666 Facsimile:
Preparation Date: March 1999
MLT R694 Ruby Laser System Device Name:
Common Name: Ruby Laser, Normal Pulse or Q-Switched Mode

Classification Laser surgical instrument for use in general and plastic surgery and in Name: dermatology (see: 21 CFR 878.4810). Product Code: GEX. Panel: 79

Legally marketed LaseAway Long Pulse and Q-Switched Ruby Laser, MM-Ruby Laser; Spectrum RD 1200; Candela AlexLAZR.
Description: The MLT R694 laser operates as a normal pulse or as a O-Switched rubv laser which emits a beam of coherent light at 694 nanometers. In the Q-Switched mode the beam has a much shorter pulse duration than in the normal or long pulse mode. The specifications for the normal or long pulse mode remain the same as described in K980187.

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The MLT R694 Ruby Laser System in the Q-Switched mode is indicated for Intended Use: cutting, vaporization, or ablation of soft tissue. This includes tatoo removal and treatment of benign pigmented lesions.
The intended uses of the MLT R 694 ruby operating in normal or long pulse mode remain the same as described in K980187.
Comparison to: The specifications of the MLT R694 laser in the O-Switched mode are the same as or very similar to those of legally marketed lasers such as the LaseAway Long Pulse and Q-Switched Ruby Laser, the MM-Ruby Laser; the Spectrum RD 1200, and the Candela AlexLAZR
Performance Data: None. The specifications and intended uses of the MLT R694 ruby system laser operating in the Q-Switched mode are the same or very similar to those of the claimed predicate devices.

Because of this, performance data were not required.

CONCLUSION: When operating in the Q-Switched mode the MLT R694 is substantially equivalent to legally marketed predicate devices, e.g., ruby and alexandrite lasers, operating in the Q-Switched mode.
The MLT R694 ruby laser system, operating in the normal mode, has been found substantially equivalent to legally marketed devices (K980187); the characteristics, specifications, and intended uses of the MLT R 694 operating in this mode are not affected by the modification to allow use in the Q-Switched mode.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 1999

Mr. David Hamilton Managing Director Medical Laser Technology, Ltd. Unit 15 Belleknowes Industrial Estate Inverkeithing Fife KY11 1HZ United Kingdom

Re: K990902

Trade Name: MLT R694 Ruby Laser System Regulatory Class: II Product Code: GEX Dated: March 16, 1999 Received: March 18, 1999

Dear Mr. Hamilton:

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 (OS) 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. David Hamilton

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your 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 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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APPENDIX B

INDICATIONS FOR USE STATEMENT

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MLT R694 RUBY LASER SYSTEM ______________________________________________________________________________________________________________________________________

Indications For Use Statement:

The MLT R694 Ruby Laser System is restricted to sale to or use by licensed professionals in the United States

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

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use
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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K990902

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.