(63 days)
Not Found
No
The summary describes a device using infrared, RF, and mechanical massage for heating and cellulite reduction. There is no mention of AI, ML, image processing, or data-driven algorithms in the intended use, device description, or performance studies.
Yes.
The device proposes to treat selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation, which are therapeutic claims.
No
The device is described as providing topical heating and mechanical manipulation for the treatment of conditions like pain relief, muscle spasms, increased circulation, and temporary reduction in the appearance of cellulite. These are therapeutic actions, not diagnostic ones.
No
The device description explicitly mentions hardware components such as a massage device, infrared light, RF device, vacuum-assisted massage with rollers, and pneumatic/mechanical manipulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for topical heating, pain relief, muscle spasms, increased local circulation, and temporary reduction in the appearance of cellulite. These are all therapeutic or aesthetic applications performed directly on the patient's body.
- Device Description: The device uses infrared light, RF energy, and mechanical massage. These are physical modalities applied externally.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with biological specimens or diagnostic purposes.
Therefore, the Cutera CMMCD device, as described, falls under the category of a therapeutic or aesthetic medical 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.
Product codes (comma separated list FDA assigned to the subject device)
NUV
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical data was needed to prove substantial equivalence.
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.
K050397 Velasmooth manufactured by Syneron Medical Ltd., K070092 Velasmooth manufactured by Syneron Medical Ltd., K071872 Velashape manufactured by Syneron Medical Ltd, K030876 Triactive manufactured by Cynosure Corporation, K990445 LPG Therapeutic Massager by LPG Systems
Reference Device(s):
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows a handwritten text string that appears to be a code or identifier. The string begins with a capital letter 'K', followed by 'o', then the numbers '80300'. The style of writing is cursive, and the numbers are connected.
Attachment 14 510(k) Summary for the Cutera CMMCD
APR - 8 2008
I. General Information
| Submitter: | Cutera, Inc. - 510(k) owner
3240 Bayshore Blvd
Brisbane, CA 94005 |
|-----------------|-------------------------------------------------------------------------|
| Contact Person: | Kathy Maynor, Acting VP of Regulatory/Quality |
| Telephone: | 415-657-5586 |
| Cell phone: | 352-586-3113 |
| Fax: | 415-330-2443 |
Summary Preparation Date: January 29, 2008
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.
Common Name: Massager, Vacuum, Light Induced Heating
III. Predicate Devices
- K050397 . Velasmooth manufactured by Syneron Medical Ltd.
- K070092 Velasmooth manufactured by Syneron Medical Ltd .
- . K071872 Velashape manufactured by Syneron Medical Ltd
- . K030876 Triactive manufactured by Cynosure Corporation
- LPG Therapeutic Massager by LPG Systems . K990445
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.
1
Premarket Notification 510(k) Submission: Cutera CMMCD
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 Cutera CMMCD has the same or similar indications for use as the listed predicate devices, and is also technologically substantially equivalent to the listed predicate devices. There are no new questions of safety or effectiveness raised by the introduction of this device. No clinical data was needed to prove substantial equivalence.
VII. Safety and Effectiveness Information
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 by the introduction of this device.
VIII. Conclusion
The Cutera CMMCD was found to be substantially equivalent to currently marketed Velasmooth/Velashape, Triactive, and LPG Endermologie devices. The Cutera CMMCD shares similar indications for use, design features, and similar functional features as these devices, and thus is substantially equivalent to the currently marketed predicate devices.
2
Public Health Service
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cutera, Inc. % Ms. Kathy Maynor Acting VP of Regulatory/Quality 3240 Bayshore Boulevard Brisbane, California 94005
APR - 8 2008
Re: K080300 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: II Product Code: NUV Dated: March 20, 2008 Received: March 24, 2008
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, 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 - 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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark N. Mullen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 2 Indications For Use Statement as Requested by FDA
510(k) Number (if Known):
Device Name: Cutera CMMCD
Indications For Use:
The Cutera CMMCD infrared 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 (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)
Niel K. Ogl-for
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number K080300