MICROWAVE DELIVERY SYSTEM, MODEL MMC-300

K991456 · Microwave Medical, Inc. · MWY · Oct 25, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991456
• Device Name: MICROWAVE DELIVERY SYSTEM, MODEL MMC-300
• Applicant: Microwave Medical, Inc.
• Product Code: MWY · General, Plastic Surgery
• Decision Date: Oct 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Microwave Delivery System (MDS) Model MMC-300 utilizes microwave energy for hair removal. Device operates by delivering microwave energy to target hair follicles. Intended for non-facial body hair removal. Operated by trained personnel in clinical settings. Output is thermal energy directed at hair follicles to achieve removal. Benefits include non-invasive hair reduction.

Clinical Evidence

No clinical data provided; document states clinical data is insufficient to demonstrate safety or effectiveness for facial hair removal.

Technological Characteristics

Microwave energy-based hair removal system. Model MMC-300. Standalone device. No specific materials or software algorithms detailed in the provided text.

Indications for Use

Indicated for removal of unwanted body hair. Contraindicated for use on facial areas.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
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