(162 days)
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.
Medlite™ Q-Switched Nd:YAG Laser
Medlite™ IV Q-Switched Nd:YAG Laser
The provided text states that "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." However, it does not detail specific acceptance criteria or an explicit study proving these criteria were met. Therefore, most of the requested information cannot be extracted from the given text.
Here is what can be inferred or explicitly stated from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated | Safe removal or lightening of unwanted hair without adverse clinical findings. |
| Not explicitly stated | Effective for hair removal or lightening in the 1064nm mode. |
2. Sample size used for the test set and data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Not specified in the provided text.
- Qualifications of Experts: Not specified in the provided text.
4. Adjudication method for the test set:
- Not specified in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- There is no mention of an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device in question is a laser system, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical laser system, not an algorithm.
7. The type of ground truth used:
- Based on the statement "safely remove or lighten unwanted hair without adverse clinical findings," the ground truth appears to be based on clinical observation of hair removal/lightening and the absence of adverse events. Specific methods for assessing hair removal/lightening success or adverse events are not detailed.
8. The sample size for the training set:
- Not applicable, as this device is a laser system and typically does not have a "training set" in the AI sense. Clinical studies involve a cohort of patients. The sample size for the clinical study (which would be analogous to a test set in a device performance study) is not provided.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of this device.
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2/10/99
510(k) Premarket Notification - Original Submission
Medlite™ Laser Systems Continuum Biomedical
August 31, 1998
983054
510(k) Summary
| Submitter: | Continuum BiomedicalA Medical Division of Continuum Electro-Optics, Inc.6533 Sierra LaneDublin, CA 94568Phone: (925) 828-3210Fax: (925) 556-2222 | |
|---|---|---|
| Contact: | Laurie A. RidenerRegulatory Affairs Officer | |
| Date Summary Prepared: | August 31, 1998 | |
| Device Trade Name: | Medlite™ Q-Switched Nd:YAG LaserMedlite™ IV Q-Switched Nd:YAG Laser | |
| Common Name: | Medical laser system | |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CRF 878.48 | |
| Equivalent Device: | Medlite™ Q-Switched Nd:YAG Laser, Medlite™ IV Q-SwitchedNd: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 adjuvantpreparation | |
| 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 safelyremove or lighten unwanted hair without adverse clinical findings. | |
| Additional Information: | None requested at this time |
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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
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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 LaserMedlite™ IV Q-Switched Nd:YAG Laser |
| Indications for Use: | For the removal or lightening of unwanted hair in the 1064nmmode only without adjuvant preparation using one or twotreatments. |
(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.
§ 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.