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.

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.

AI/ML Overview

This 510(k) submission for the Cutera CMMCD (K092195) is a Special 510(k), which indicates that it is a modification to a previously cleared device. Special 510(k)s typically do not require new clinical studies if the changes do not affect the fundamental scientific technology or intended use. Instead, they rely on demonstrating that the performance and technical specification changes fall within FDA regulations for such modifications and that the modified device is substantially equivalent to predicate devices.

Therefore, the provided document does not contain a detailed study with acceptance criteria, sample sizes, ground truth establishment, or human reader performance data as would be found in a traditional 510(k) or PMA for an entirely new device or a significant change in indications. The core of this submission is a declaration of substantial equivalence based on the nature of the modifications.

Here's a breakdown based on the information available, and what cannot be answered from this specific document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "acceptance criteria" for a Special 510(k) primarily revolve around the device's technical specifications and safety profile remaining within acceptable bounds given the modifications, and demonstrating substantial equivalence to predicate devices. The implicit acceptance criterion is that the modified device performs as safely and effectively as its predicate and the original device, for the stated indications.
Reported Device Performance: The document states:
- "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."
- The device is indicated for "relief of minor muscle aches and pains, relief of muscle spasms, temporary improvement in local circulation" (for the optional infrared/RF device) and "temporary improvement in the appearance of cellulite" (for the massage device).
Since this is a Special 510(k) for modifications, these performance claims are likely based on the performance demonstrated by the original device and the predicate devices, rather than new performance data for these specific modifications.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable / Not Provided: This document does not describe a new clinical study with a test set. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) is not available.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable / Not Provided: As no new clinical study test set is described, there's no mention of experts used for ground truth.

4. Adjudication Method for the Test Set:

Not Applicable / Not Provided: No test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No: This document does not mention an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study was Done:

No: This device is a physical medical device (massage and RF/infrared) and does not involve an algorithm in the AI/standalone software sense. Therefore, this is not applicable.

7. The Type of Ground Truth Used:

Not Applicable / Not Provided: No new clinical study requiring ground truth establishment is described. The "ground truth" for the device's indications (e.g., temporary improvement in cellulite) would have been established through previous clinical studies for the original device and its predicates, usually involving clinical assessments, patient reported outcomes, and potentially photographic documentation.

8. The Sample Size for the Training Set:

Not Applicable / Not Provided: As there is no AI algorithm involved, there is no training set in this context.

9. How the Ground Truth for the Training Set was Established:

Not Applicable / Not Provided: No AI algorithm or training set.

Summary for K092195 (Cutera CMMCD):

This submission is a Special 510(k) for modifications to an existing device. It establishes substantial equivalence by demonstrating that the changes do not raise new questions of safety or effectiveness, and that the device's performance and technical specifications align with its predicate. It does not present new clinical study data with explicit acceptance criteria, performance metrics, sample sizes, or ground truth establishment based on a new study for the modified device. The performance claims listed are based on the cleared indications for the original device and predicate devices.

Summary

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Premarket Notification Special 510(k) Submission: Cutera CMMCD

K092195

Attachment 8 510(k) Summary for the Cutera CMMCD

I, General Information

OCT - 1 2009

Submitter:	Cutera, Inc. - 510(k) owner3240 Bayshore BlvdBrisbane, 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

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V. Statement of Intended Use

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 massage device is intended to provide a temporary reduction in the appearance of cellulite.

Prescription Use V (Per 21 CFR 801.109)

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

Regulation Number and Section

§ 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.