(182 days)
The Microwave Medical Corporation, Microwave Delivery System (Model MMC-300) is designed for the removal of unwanted body hair except on facial areas. This device is not for use on facial areas. Clinical data to date is not sufficient to demonstrate safety or effectiveness on facial areas.
Microwave Delivery System (MDS), Model MMC-300
This document is a 510(k) premarket notification decision letter from the FDA. It approves a device for market but does not contain a detailed study report with acceptance criteria and specific performance metrics. Therefore, I cannot extract the requested information.
The document states: "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... You may, therefore, market the device..."
This indicates that the device was approved based on its substantial equivalence to a legally marketed predicate device, rather than through a detailed study proving it meets specific, predefined acceptance criteria that are reported in this document. The "Indications For Use" section explicitly states: "Clinical data to date is not sufficient to demonstrate safety or effectiveness on facial areas." This further confirms the absence of detailed efficacy or safety study results in this particular approval letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 1999
Microwave Medical, Inc. c/o Greg Holland Holland & Associates 3722 Avenue Sausalito Irvine, California 92606
Re: K991456
Trade Name: Microwave Delivery System (MDS), Model MMC-300 Regulatory Class: II Product Code: MWY Dated: July 29, 1999 Received: August 2, 1999
Dear Mr. Holland:
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 (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.
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Page 2 - Mr. Greg Holland
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,
pcollefa
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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Page 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Microwave Medical Corporation, Microwave Delivery System (Model MMC-300) is designed for the removal of unwanted body hair except on facial areas.
This device is not for use on facial areas. ^ Clinical data to date is not sufficient to demonstrate safety or effectiveness on facial areas.
(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 | K991456 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.