(70 days)
Not Found
No
The document describes a laser system and its intended uses, but there is no mention of AI or ML technology in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
Yes
The device is indicated for medical procedures such as "tattoo removal and treatment of benign pigmented lesions," which are therapeutic interventions.
No
The MLT R694 Ruby Laser System is indicated for cutting, vaporization, or ablation of soft tissue, such as for tattoo removal, which are therapeutic rather than diagnostic applications.
No
The device description clearly states it is a "Ruby Laser System" which is a hardware device that emits a beam of light.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cutting, vaporization, or ablation of soft tissue, specifically for tattoo removal and treatment of benign pigmented lesions. This is a therapeutic or surgical application, not a diagnostic one.
- Device Description: The device is a laser system that emits light to interact with tissue. This is consistent with a therapeutic device, not a device used to examine samples outside the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
The information provided clearly describes a medical device used for direct treatment of the patient's body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
Device Description
The MLT R694 laser operates as a normal pulse or as a Q-Switched ruby 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
restricted to sale to or use by licensed professionals in the United States
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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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.
2
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 (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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K990902 |
Concurrence of CDRH, Office of Device Evaluation (ODE)