(213 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any related concepts. The description focuses on the intended use and handpiece specifications.
Yes
The device is indicated for the treatment of benign pigmented lesions, benign vascular lesions, and hair removal, which are medical treatments or procedures.
No
The device is indicated for treatment (benign pigmented lesions, benign vascular lesions, hair removal), not for diagnosing conditions.
No
The device description explicitly mentions "handpiece," which is a hardware component of a medical device, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes treatment of skin conditions (pigmented lesions, vascular lesions, hair removal). This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description "SmoothCool" and the mention of handpieces with specific wavelengths (560nm, 700nm) strongly suggest a light-based or energy-based device used for direct treatment on the body.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the SmoothCool device, as described, is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The left handpiece (560nm) of the SmoothCool is indicated for the treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benigh vascular lesions (diffuse redness). The right handpiece (700nm) is indicated for hair removal (permanent hair reduction).
Product codes
ONF
Device Description
SmoothCool appears to be a device with two handpieces: a left handpiece with a 560nm wavelength and a right handpiece with a 700nm wavelength. Its use described is for the treatment of benign pigmented lesions, benign vascular lesions, and hair removal.
Mentions image processing
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Mentions AI, DNN, or ML
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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
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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 the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JM Systems Co. Ltd. % Regulatory Insight, Inc. Mr. Kevin Walls, RAC 5401 South Cottonwood Court Greenwood Village, Colorado 80121
MAR - 5 2010
Re: K092326
Trade/Device Name: Smoothcool 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: ONF Dated: March 3, 2010
Received: March 4, 2010
Dear Mr. Walls:
We have reviewed your Section 5 1 0(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 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
1
Page 2 - Mr. Kevin Walls, RAC
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 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/CDRHOffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K09 2326
Device Name: SmoothCool
The left handpiece (560nm) of the SmoothCool is indicated for the treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benigh vascular lesions (diffuse redness). The right handpiece (700nm) is indicated for hair removal (permanent hair reduction).
Prescription Use × (Part 21 CFR 801 Subpart D)
الموالي المتحدة المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المن
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nilford Ode Carmen
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092326
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