(73 days)
EpiLaser8, Chromos 694, EpiTouch
Not Found
No
The summary describes a laser system for hair removal and does not mention any AI or ML components or functionalities.
No.
The device is intended to remove unwanted body hair, which is a cosmetic procedure and not typically considered therapeutic unless it is treating a medical condition like excessive hair growth due to a disease.
No
The device is intended to remove unwanted body hair, which is a treatment, not a diagnosis.
No
The device description clearly states it is a "ruby laser system" which emits a beam of coherent light, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to remove unwanted body hair." This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- Device Description: The device is a laser system that emits light. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis or treatment decisions based on in vitro analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This laser system does not fit that description.
N/A
Intended Use / Indications for Use
The MLT R694 Ruby Laser System is intended to remove unwanted body hair.
Product codes
GEX
Device Description
The MLT R694 laser is a normal or long pulse ruby laser which emits a beam of coherent light at 694 nanometers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The specifications and indications for use of the MLT R694 ruby system laser are the same or very similar to those of the claimed predicate devices. Because of this, performance data were not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EpiLaser8, Chromos 694, EpiTouch
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
K980187
APR - 3 1998
APPENDIX E
510(k) SUMMARY MEDICAL LASER TECHNOLOGIES LTD MLT R694 RUBY LASER SYSTEM
This 510(k) summary of safety and effectiveness for the diode surgical 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.
MEDICAL LASER TECHNOLOGIES LTD Applicant:
- Address: Unit 4 Belleknowes Industrial Estate Inverkeithing Fife KY11 1HY United Kingdom
- David Hamilton Contact Person: Managing Director
- Telephone: +44 1383 411555 +44 1383 411666 (Fax)
Preparation Date: January 1998 (of the Summary)
-
Device Name: MLLT R694 Ruby Laser System
Common Name: Ruby Laser, Long or Normal Pulse -
Laser surgical instrument for use in general and plastic surgery and in Classification dermatology (see: 21 CFR 878.4810). Name: Product Code: GEX. Panel: 79
EpiLaser8, Chromos 694, and the EpiTouch lasers among others. Legally marketed predicate devices:
The MLT R694 laser is a normal or long pulse ruby laser which emits a Description of beam of coherent light at 694 nanometers. the Device:
The MLT R694 laser is intended for the removal of unwanted body hair. Indications for Use: ﺘﻮ
1
- Comparison to: The specifications of the MLT R694 laser are the same as or very similar to those of legally marketed lasers such as the EpiLaser", the Chromos 694, and the EpiTouch.
None. The specifications and indications for use of the MLT R694 ruby Performance Data: system 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 hair removal, Medical Laser Technologies Ltd. believes that the MLT R694 ruby laser system is substantially equivalent to legally marketed predicate devices.
، ﭘ
C 84
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 1998
Mr. David C. Hamilton Managing Director Medical Laser Technologies Limited Unit 4 Belleknowes Industrial Estate Inverkeithing, Fife KY11 1HY United Kingdom
Re: K980187 MLT R694 Ruby Laser System Trade Name: Regulatory Class: II Product Code: GEX Dated: January 16, 1998 Received: January 20, 1998
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. ਸ 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 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.
3
Page 2 - Mr. 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 requlation (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
Mia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX B
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
INDICATIONS FOR USE STATEMENT
| 510/X) N |
ALL AN E LEBELEAN
STATION OF CHARGE |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| 1 T D 401
AVI
CONTRACT A COLLECT OF COLLECTION OF CLEASE
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | המחזמות
CALLERS AND CONSULTION COLLEGION
ALLE OF CORRESS |
Indications For Use Statement:
The MLT R694 Ruby Laser System is intended to remove unwanted body hair.
Patient selection criteria include patients with skin types 1-4.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) ...
Prescription Use (Per 21 CFR 801. 109)
ﺴﺔ
OR Over-The-Counter Use
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980187