DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM

K024307 · Sybaritic, Inc. · IMI · Jul 2, 2003 · Physical Medicine

Device Facts

• Record ID: K024307
• Device Name: DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
• Applicant: Sybaritic, Inc.
• Product Code: IMI · Physical Medicine
• Decision Date: Jul 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

a. Therapeutic Massager: - Provides temporary relief of minor muscle aches and pains i. - Relieves muscle spasms ii. - Temporarily improves local blood circulation jii. - Temporarily reduces the appearance of cellulite iv. b. Ultrasonic Diathermy : - Relief of pain i. - Muscle spasms ii. - iii. Joint contractures - iv. NOT for the treatment of malignancies

Device Story

Dermosonic Non-Invasive Subdermal Therapy System combines ultrasonic diathermy and mechanical massage. Device utilizes ultrasonic energy for deep tissue heating and mechanical stimulation for subdermal tissue manipulation. Operated by clinicians in professional settings. Output includes thermal effects for pain/spasm relief and mechanical action for circulation/cellulite appearance reduction. Healthcare providers use device to address musculoskeletal conditions and aesthetic concerns. Benefits include non-invasive symptom management and temporary cosmetic improvement.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to legally marketed predicate devices.

Technological Characteristics

System integrates ultrasonic diathermy (21 CFR 890.5300) and therapeutic massager (21 CFR 890.5660). Energy source: electrical/ultrasonic. Form factor: clinical therapy system. Class II (diathermy) and Class I (massager).

Indications for Use

Indicated for patients requiring temporary relief of minor muscle aches, pains, muscle spasms, joint contractures, improved local blood circulation, and temporary reduction in cellulite appearance. Contraindicated for treatment of malignancies.

Regulatory Classification

Identification

An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Submission Summary (Full Text)

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Public Health Service

2 2003 JUL

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Randall E. Berglund, General Counsel Sybaritic, Inc. 9220 James Avenue South Minneapolis, Minnesota 55431

Re: K024307

Trade/Device Name: Dermosonic Non-Invasive Subdermal Therapy System Regulation Number: 21 CFR 890.5300, 21 CFR 890.5660 Regulation Name: diathermy, ultrasonic; massager, therapeutic Regulatory Class: Class II, Class I Product Code: IMI, ISA Dated: April 1, 2003 Received: April 3, 2003

Dear Mr. Berglund:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Mr. Ronald E. Berglund

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark N Mather

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indications for Use

**510(k) Number:** K024307

Dermosonic Non-Invasive Subdermal Therapy System Device Name:

Indications for use include the following:

- a. Therapeutic Massager:
- Provides temporary relief of minor muscle aches and pains i.
- Relieves muscle spasms ii.
- Temporarily improves local blood circulation jii.
- Temporarily reduces the appearance of cellulite iv.
- b. Ultrasonic Diathermy :
- Relief of pain i.
- Muscle spasms ii.
- iii. Joint contractures
- iv. NOT for the treatment of malignancies

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Over-the-Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Manh Milkence of CDRH
00

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

K024307

(Division Sign-Off) Division of General Restorative Devices 510(k) Number:

(Per 21 CFR 801.109)