The M.L.T. 30 CO2 laseris intended for the ablation, vaporization, incision, and or cutting of soft tissue in: Oral surgery, Dermatology, E.N.T., Gynaecology.

Device Description

The Medical Laser Technologies Ltd. MLT 30 CO2 Laser emits a beam of coherent light at 10.6 microns.

AI/ML Overview

The provided text describes a 510(k) summary for the Medical Laser Technologies Ltd. MLT 30 CO2 Laser. This submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance data from a new study.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not applicable.	Not applicable. The device's specifications and indications for use are stated to be the same as or very similar to the predicate device. Performance data was not required because of this similarity.

2. Sample size used for the test set and the data provenance

Sample size: Not applicable. No new test set data was generated or used as performance data was not required.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new test set data was generated or used.

4. Adjudication method for the test set

Not applicable. No new test set data was generated or used.

5. 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 is a medical device (laser) and not an AI-based diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a medical device (laser) and not an AI-based algorithm. No standalone performance study was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The submission relies on substantial equivalence to a predicate device, not on new clinical performance data with ground truth.

8. The sample size for the training set

Not applicable. This product is a conventional medical laser, not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary of Device Acceptance:

The acceptance of the MLT 30 CO2 Laser was based on demonstrating substantial equivalence to a previously legally marketed predicate device (Medical Laser Technology, Inc. M.L.T. 30 CO2 Laser). The key argument for acceptance was that the new device's specifications and indications for use are the same as or very similar to those of the predicate device. Therefore, no new performance data or clinical studies were conducted or required for this 510(k) submission.

Summary

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K982548

APPENDIX E

510(k) SUMMARY MEDICAL LASER TECHNOLOGIES LTD MLT 30 CO, LASER

This 510(k) summary of safety and effectiveness for the Medical Laser Technologies Ltd. MLT 30 CO2 laser 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.

Applicant: MEDICAL LASER TECHNOLOGIES LTD

Address: Unit 4 Belleknowes Industrial Estate Inverkeithing Fife KY11 1HY United Kingdom
Contact Person: David Hamilton Managing Director
Telephone: +44 1383 411555 +44 1383 411666 (Fax)

Preparation Date: July 1998 (of the Summary)

Device Name: MLT 30 CO. Laser

Common Name: CO2 Laser

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 Medical Laser Technology, Inc. M.L.T. 30 CO, Laser predicate device:

The Medical Laser Technologies Ltd. MLT 30 CO2 Laser emits a beam of Description of the Device: coherent light at 10.6 microns.

Indications for The CO2 Laser is intended for the ablation, vaporization, incision, excision, use: or cutting of soft tissue in oral surgery, E.N.T., gynecology, and dermatology.
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The specifications of and indications for the Medical Laser Technologies Ltd. Comparison to: 30 CO2 Laser are the same as or very similar to those of the claimed predicate, the M.L.T. 30 marketed by Medical Laser Technology, Inc.

Performance Data: None: The specifications and indications for use of the Meditec Laser Technologies Ltd. 30 CO, laser are the same or very similar to those of the claimed predicate devices.

Because of this, performance data were not required.

CONCLUSION: Based on the similarities of specifications and indications for use for ablation, vaporization, incision, excision, or cutting of soft tissue in a number of surgical specialties Medical Laser Technologies Ltd. believes that the 30 CO2 Laser described in this notification is substantially equivalent to the cited legally marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 1998

Medical Laser Technologies, Ltd. c/o Mr. William Kelley 23832 Via Monte Coto De Caza, California 92679-4001

K982548 Re: MLT 30 Trade Name: II Regulatory Class: Product Code: GEX July 21, 1998 Dated: Received: July 21, 1998

Dear Mr. Kelley:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ 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 In addition, FDA may publish further announcements action. 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 requlations.

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Page 2 - Mr. William Kelley

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 gener 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

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX B rev. 10/98

INDICATIONS FOR USE STATEMENT

510(K) Number (if known):	K982548
Device Name:	M.L.T. 30 CO₂ laser

Indications For Use Statement:

The M.L.T. 30 CO2 laseris intended for the ablation, vaporization, incision, and or cutting of soft tissue in:

Oral surgeryDermatology
	Examples: Removal of small skin tumors, superficial pigmented lesions, adeno-sebaceous hypertrophy, treatment of scars, skin tags, etc.
	Skin resurfacing (scanning mode)
	Blepharoplasty
E.N.T.
	Examples: Tumor surgery of the larynx and pharynx
	LAUP
	Stenosis
	CAUTION: Patients should be diagnosed with tissue problems to exclude thosewhose problems are caused by being overweight or to drinkingproblems.
	Remind patients that there may be vocalization problems after lasersurgery.

Gynaecology

The examples are not intended to be exhaustive or complete but to serve as a general guide to the surgeon.

Meditec Laser Fechnologies proposes that the M.L.T. 30 CO2 laser be limited to prescription use. This labeling will be included in the final printing of the manual and on literature relating to the device.

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

Concurrence of CDRH, Office of Device Evaluation (OFFICE OF DEVICE EVALUATION)

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
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Division Sign-Off
of General Restorative Devices
510(k) Number: K982548

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.