(72 days)
Not Found
No
The document describes a device using infrared, RF, and massage technologies for physical effects, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
Yes
The device is indicated for the relief of minor muscle aches and pains, relief of muscle spasms, and temporary improvement in local circulation, which are therapeutic uses.
No
The device's stated "Intended Use / Indications for Use" are for the relief of minor muscle aches and pains, muscle spasms, temporary improvement in local circulation, and temporary improvement in the appearance of cellulite, which are all therapeutic, not diagnostic.
No
The device description explicitly states it consists of a "massage device and an infrared light(optional)/RF device," indicating hardware components are integral to its function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Cutera CMMCD device uses infrared/RF energy and massage to treat the body directly (topical heating, mechanical manipulation). It does not analyze samples taken from the body.
- Intended Use: The intended uses listed (relief of muscle aches/spasms, improved circulation, temporary improvement in cellulite appearance) are all related to treating the body externally, not diagnosing conditions through sample analysis.
Therefore, the description clearly indicates a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cutera CMMCD optional infrared/RF device is indicated for the relief of minor muscle aches and pains, relief of muscle spasms, temporary improvement in local circulation. The Cutera CMMCD massage device is indicated for the temporary improvement in the appearance of cellulite.
The Cutera CMMCD infrared(optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
The Cutera CMMCD massage device is intended to provide a temporary reduction in the appearance of cellulite.
Product codes (comma separated list FDA assigned to the subject device)
NUV, GEI, ISA
Device Description
The Cutera CMMCD treatment consists a massage device and an infrared light(optional)/RF device. Topical heating for the purpose of elevating tissue temperature is derived from conducted RF energy/optional infrared light. Mechanical manipulation is derived from a vacuum assisted massage with rollers. The pneumatic/mechanical manipulation of the skin is sufficient to provide mild transient erythema and produces a temporary improvement in the appearance of cellulitic skin where applied.
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
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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Premarket Notification Special 510(k) Submission: Cutera CMMCD
Attachment 8 510(k) Summary for the Cutera CMMCD
I, General Information
OCT - 1 2009
| Submitter: | Cutera, Inc. - 510(k) owner
3240 Bayshore Blvd
Brisbane, CA 94005 |
|-----------------|-------------------------------------------------------------------------|
| Contact Person: | Kathy Maynor, VP of Regulatory/Quality |
Telephone: 415-657-5586 Cell phone: 352-586-3113 Fax: 415-330-2443
Summary Preparation Date: July 1, 2009
II. Names
Device Proprietary Name: Cutera CMMCD
Primary Classification Name: Massager, Vacuum, Light Induced Heating - assigned to 21 CFR 878.4810 (Laser surgical instrument for use in general and plastic surgery and in dermatology). The Product Code is NUV.
Massager, Vacuum, Light Induced Heating Common Name:
III. Predicate Devices
- . K082622 Alma Lasers Accent Uniform Massager Handpiece
IV. Product Description/Technological Characteristics
The Cutera CMMCD treatment consists a massage device and an infrared light(optional)/RF device. Topical heating for the purpose of elevating tissue temperature is derived from conducted RF energy/optional infrared light. Mechanical manipulation is derived from a vacuum assisted massage with rollers. The pneumatic/mechanical manipulation of the skin is sufficient to provide mild transient erythema and produces a temporary improvement in the appearance of cellulitic skin where applied.
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V. Statement of Intended Use
The Cutera CMMCD optional infrared/RF device is indicated for the relief of minor muscle aches and pains, relief of muscle spasms, temporary improvement in local circulation. The Cutera CMMCD massage device is indicated for the temporary improvement in the appearance of cellulite.
VI. Rationale for Substantial Equivalence
The performance and technical specification changes to the CMMCD fall within the FDA regulations for the special 510(k). A discussion of the changes was provided as well as an additional predicate device.
Safety and Effectiveness Information VII.
Technologically, the Cutera CMMCD is substantially equivalent to the listed predicate devices. Therefore the risks and benefits for the Cutera CMMCD are comparable to the predicate devices.
We therefore believe that there are no new questions of safety or effectiveness raised.
VIII. Conclusion
The Cutera CMMCD, as modified by this special 510(k), does not raise any new issues regarding safety or effectiveness, and therefore is suitable for sale as a prescription medical device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Cutera, Inc. % Ms. Kathy Maynor VP of Regulatory/Quality 3240 Bayshore Boulevard Brisbane, California 94005
OCT - 1 2009
Re: K092195
Trade/Device Name: Cutera CMMCD Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery
and in dermatology
Regulatory Class: Class II Product Code: NUV, GEI, ISA Dated: August 25, 2009 Received: September 1, 2009
Dear Ms. Maynor:
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. Ilsting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Kathy Maynor
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
incerely yours,
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2 Indications For Use Statement as Requested by FDA
510(k) Number (if Known): K072195
Device Name: Cutera CMMCD
Indications For Use:
The Cutera CMMCD infrared(optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
The Cutera CMMCD massage device is intended to provide a temporary reduction in the appearance of cellulite.
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nielke Slu formxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092195