(162 days)
Not Found
No
The summary describes a laser device for hair removal and does not mention any AI or ML components or functionalities.
Yes.
The device is used for the removal or lightening of unwanted hair, which is a therapeutic purpose.
No
Explanation: The device is described as a laser system for the removal or lightening of unwanted hair, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states "Medlite™ Q-Switched Nd:YAG Laser" and "Medlite™ IV Q-Switched Nd:YAG Laser," which are hardware-based laser systems. The intended use also describes a physical action (removal or lightening of hair) performed by a laser.
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 laser system. Lasers used for hair removal operate externally on the skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are specifically designed to perform tests on samples taken from the human body to aid in diagnosis, monitoring, or screening. This device's function is entirely different.
N/A
Intended Use / Indications for Use
For the removal or lightening of unwanted hair without adjuvant preparation.
For the removal or lightening of unwanted hair in the 1064nm mode only without adjuvant preparation using one or two treatments.
Product codes (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data was provided to support the use of the Medlite™ Q-Switched Nd:YAG Laser Systems without preparatory lotion to safely remove or lighten unwanted hair without adverse clinical findings.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
2/10/99
510(k) Premarket Notification - Original Submission
Medlite™ Laser Systems Continuum Biomedical
August 31, 1998
983054
510(k) Summary
| Submitter: | Continuum Biomedical
A Medical Division of Continuum Electro-Optics, Inc.
6533 Sierra Lane
Dublin, CA 94568
Phone: (925) 828-3210
Fax: (925) 556-2222 | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Laurie A. Ridener
Regulatory Affairs Officer | |
| Date Summary Prepared: | August 31, 1998 | |
| 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: | Medlite™ Q-Switched Nd:YAG Laser, Medlite™ IV Q-Switched
Nd:YAG Laser (K973719, SE date 12/23/97)
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 without adjuvant
preparation | |
| Comparison: | Equivalent | |
| Nonclinical Performance Data: | None | |
| Clinical Performance Data: | Clinical data was provided to support the use of the Medlite™ Q-
Switched Nd:YAG Laser Systems without preparatory lotion to safely
remove or lighten unwanted hair without adverse clinical findings. | |
| 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human figures in profile, facing to the right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1999
Ms. Laurie A. Ridener Regulatory Affairs Officer Continuum Biomedical 6533 Sierra Lane Dublin, California 94568
Re: K983054
Trade Name: Medlite™ Q-Switched Nd:YAG Laser Medlite™ IV Q-Switched Nd:YAG Laser Regulatory Class: II Product Code: GEX Dated: December 3, 1998 Received: December 4, 1998
Dear Ms. Ridener:
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 (OS) 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.
2
Page 2 - Ms. Laurie A. Ridener
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,
peoleda
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
510(k) Premarket Notification - Original Submission Medlite™ Laser Systems Continuum Biomedical Revised February 5, 1999
Page 1 of 1
P.
| 510(k) Number (if known): | K983054 |
|---|---|
| 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 without adjuvant preparation using one or two | |
| treatments. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K483054 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
OR
Over-the-Counter Use ______ (Optional Format 1-2-96)PROPRIETARY DATA: This document and information contained berrin may not be reproduced, wood or disclosed without written partission of Continuen Biomedical A Medial Dricion of Continuan Plection Optics, Inc.