(308 days)
Not Found
Not Found
No
The device description and intended use do not mention any AI or ML capabilities. The core technology is described as pulsatile vacuum action.
Yes
The device is described as relieving muscle aches, pain, and spasm, improving local circulation, and reducing cellulite, all of which are therapeutic effects. Furthermore, its predicate device is a "Therapeutic Massager and Vibrator".
No
The device description and intended use do not mention any function related to diagnosing medical conditions. Its uses are focused on relieving symptoms and cosmetic improvements.
No
The device description explicitly states it utilizes "pulsatile vacuum action," which is a hardware-based mechanism, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (relieving muscle aches, spasms, improving circulation, reducing cellulite) are all related to physical therapy and aesthetic treatments, not the diagnosis of diseases or conditions through the examination of specimens taken from the human body.
- Device Description: The device description mentions "pulsatile vacuum action to achieve massaging results," which aligns with a physical therapy or aesthetic device, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function and intended uses clearly fall outside of that scope.
N/A
Intended Use / Indications for 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.
- Relieves minor muscle aches and pains.
- Relieve muscle spasm
- Temporary Improvement in local circulation
- Temporarily reduces the appearance of cellulite.
Product codes
ILY, ISA
Device Description
The TriActive system utilizes pulsatile vacuum action to achieve massaging results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics
Not Found
Predicate Device(s)
LPG Therapeutic Massager and Vibrator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5660 Therapeutic massager.
(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
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510(k) SUMMARY
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
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
21 CFR 890.5660 |
| Equivalent Device: | LPG Therapeutic Massager and Vibrator |
| Device Description: | The TriActive system utilizes pulsatile vacuum action to
achieve massaging results. |
| 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. |
| 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
safe and effective device for the indications. |
| Additional Information: | none |
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Image /page/1/Picture/1 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is an image of a bird.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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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