(84 days)
No
The summary describes a laser device for hair removal and does not mention any AI or ML components or capabilities.
No
The device is used for cosmetic purposes (hair removal/lightening) and not for treating a medical condition or disease.
No
Explanation: The device is described as a laser for hair removal, which is a therapeutic or cosmetic procedure, not a diagnostic one. There is no mention of it identifying or analyzing health conditions.
No
The device description explicitly states it is a "Q-Switched Nd:YAG Laser," which 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 "For the removal or lightening of unwanted hair". This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- Device Description: The device is a "Q-Switched Nd:YAG Laser". Lasers used for hair removal are medical devices that interact with tissue, not diagnostic tools that analyze samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or other materials to perform tests on samples.
IVDs are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to remove hair, which is a physical intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
For the removal or lightening of unwanted hair in the 1064nm mode only.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Nonclinical Performance Data: None
Clinical Performance Data: Authorization provided to access data in K950019
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
K973719
510(k) Summary
DEC 2 3 1997
| Submitter: | Continuum Biomedical
A Medical Division of Continuum Electro-Optics, Inc.
6533 Sierra Lane
Dublin, CA 94568
Phone: (510) 828-3210
Fax: (510) 556-2222 | | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact: | Laurie A. Ridener
Regulatory Affairs Officer | | |
| Date Summary Prepared: | September 29, 1997 | | |
| Device Trade Name: | Medlite™ Q-Switched Nd:YAG Laser
Medlite™ IV Q-Switched Nd:YAG Laser | | |
| Common Name: | Medical laser system | | |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CRF 878.48 | | |
| Equivalent Device: | ThermoLase LT-100 Nd:YAG Laser Hair Removal System
(K950019, SE Date 04-03-95) | | |
| Intended Use: | For the removal or lightening of unwanted hair | | |
| Comparison: | Equivalent | | |
| Nonclinical Performance Data: | None | | |
| Clinical Performance Data: | Authorization provided to access data in K950019 | | |
| Conclusion: | The Medlite Laser Systems can be safely used to remove or lighten
unwanted hair | | |
| Additional Information: | None requested at this time | | |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1997
Ms. Laurie A. Ridener Regulatory Affairs Officer Continuum Biomedical, Incorporated 6533 Sierra Lane Dublin, California 94568
Re: K973719
Trade Name: Medlite™ Q-Switched Nd: YAG Laser, Medlite IV Q-Switched Nd: YAG Laser Regulatory Class: II Product Code: GEX Dated: September 29, 1997 Received: September 30, 1997
Dear Ms. Ridener:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542
2
Page 2 - Ms. Ridener
of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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
3
长973719 510(k) Number (if known):
Device Name:
Medlite™ Q-Switched Nd:YAG Laser Medlite™ IV Q-Switched Nd:YAG Laser
Indications for Use:
For the removal or lightening of unwanted hair in the 1064nm mode only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDR Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number |
Prescription Use /
OR
Over-the-Counter Use ____
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
PROPRIETARY DATA: This document and information contained herein may not be reproduced, used or disclosed without written permission of Continuum Biomedical, A Medical Division of Continuum Electro-Optics, Inc.