CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM

K030876 · Cynosure, Inc. · ISA · Jan 22, 2004 · Physical Medicine

Device Facts

• Record ID: K030876
• Device Name: CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM
• Applicant: Cynosure, Inc.
• Product Code: ISA · Physical Medicine
• Decision Date: Jan 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5660
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The TriActive is indicated for minor muscle aches, pain, and spasm. It is also indicated for improvement in local circulation and reduction in the appearance of cellulite.

Device Story

The Cynosure TriActive Therapeutic Massage System utilizes pulsatile vacuum action to provide therapeutic massage. The device is intended to relieve minor muscle aches, pains, and spasms, improve local circulation, and temporarily reduce the appearance of cellulite. It functions as a therapeutic massager.

Clinical Evidence

No clinical data provided; no nonclinical performance data provided.

Technological Characteristics

Utilizes pulsatile vacuum action for therapeutic massage. Classified under 21 CFR 890.5660 (Therapeutic massager) and 21 CFR 890.5500 (Infrared Lamp).

Indications for Use

Indicated for relief of minor muscle aches, pains, and muscle spasms; temporary improvement in local circulation; and temporary reduction in the appearance of cellulite.

Regulatory Classification

Identification

A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.

Predicate Devices

• LPG Therapeutic Massager and Vibrator

Submission Summary (Full Text)

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## 510(k) SUMMARY

| Submitter: | Cynosure, Inc.<br>10 Elizabeth Drive<br>Chelmsford, MA 01824 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | March 19, 2003 |
| Device Trade Name: | Cynosure TriActive Therapeutic Massage System |
| Common Name: | Therapeutic Massager |
| Classification Name: | Therapeutic Massager<br>21 CFR 890.5660 |
| Equivalent Device: | LPG Therapeutic Massager and Vibrator |
| Device Description: | The TriActive system utilizes pulsatile vacuum action to<br>achieve massaging results. |
| Intended Use: | The TriActive is indicated for minor muscle aches, pain,<br>and spasm. It is also indicated for improvement in local<br>circulation and reduction in the appearance of cellulite. |
| Comparison: | It has the same indications as the predicate device. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The TriActive Therapeutic Massage System is another<br>safe and effective device for the indications. |
| Additional Information: | none |

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Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

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JAN 3 0 2005

Mr. George Cho Senior Vice President Cynosure. Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824-4145

Re: K030876

Trade/Device Name: Cynosure Triactive Therapeutic Massage System Regulation Number: 21 CFR 890.5500, 21 CFR 890.5660 Regulation Name: Infrared Lamp, Therapeutic massager Regulatory Class:II Product Code: ILY, ISA Dated: December 18, 2003 Received: December 19, 2003

Dear Mr. Cho:

This letter corrects our letter of January 22, 2004 regarding the regulation name, regulatory class and product code of the Cynosure Triactive Therapeutic Massager.

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 enclosurc) to legally marketed predicate devices murketed 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 (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 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 complics 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 (121

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## Page 2 - Mr. George Cho

forth in the quality systems (QS) 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 continue 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/cdrl/industry/support/index.html.

Sincerely yours,

Mark A. Milkerson

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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## Indications for Use

50)(k) Number (if known): K030876

Device Name:

Cynosure TriActive Therapeutic Massage System

Indications For Use:

- Relieves minor muscle aches and pains .
- 1 Relieve muscle spasm
- Temporary Improvement in local circulation 8
- Temporarily reduces the appearance of cellulite .

Prescription Usc (Per 21 CFR 801 Subpart D) AND / OR

Over-the-Counter Use (Per 21 CFR 807 Subpan C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) ﺎ Division of (-auces , Fran and Neurological Concess KO SUY 510(k) Number

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