(155 days)
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No
The provided text describes a light-based skin treatment system with various wavelengths for different applications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description or intended use.
Yes
The device is indicated for the treatment of various medical skin conditions such as pigmented and vascular lesions, inflammatory acne, and benign pigmented epidermal and cutaneous lesions, as well as permanent hair reduction. These are considered therapeutic applications.
No
The intended uses listed (hair removal, treatment of pigmented and vascular lesions, inflammatory acne, warts, scars, striae) are all therapeutic or aesthetic treatments, not diagnostic processes.
No
The intended use and description clearly indicate the device includes hardware components (handpieces with specific wavelengths and contact cooling) for aesthetic and medical dermatology treatments, which are physical interventions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The description clearly states the device is a "Skin Care system" intended for "aesthetic applications and for selective treatments required by medical dermatology specialties." The listed indications for use (hair removal, treatment of lesions, acne, warts, scars, striae) are all procedures performed directly on the patient's skin (in vivo).
- Lack of Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on materials taken from the body.
Therefore, this device falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Skin Care system is intended for aesthetic anplications and for selective treatments required by medical dermatology specialties.
The skin care system and optional Hand pieces with 420 - 1050 nm wavelengths, with and without contact cooling, is indicated for, but not limited to:
- Hair removal and Permanent Hair Reduction in all skin types (1-VI) to the Fitzpatrick scale
- Recommended wavelengths in the range of 670-1050 nm, 755-950 nm or 580-1050 nm
- Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale
- Recommended wavelength in the range of 515-950 nm
- Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale
- Recommended wavelength in the range of 420-950 nm
- Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (1-VI) to the Fitzpatrick scale
- Recommended wavelength in the range of 560-950 nm
Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Product codes
GEX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2016
C.I.S. Ltd. Mr. Ilan Sharon 4 Ben Gurion St. Nes Ziona 7403201, Israel
Re: K152736 Trade/Device Name: Skin Care 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: GEX Dated: February 7, 2016 Received: February 11, 2016
Dear Mr. Sharon:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 and 809); 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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152736
Device Name
Skin care
Indications for Use (Describe)
The Skin Care system is intended for aesthetic anplications and for selective treatments required by medical dermatology specialties.
The skin care system and optional Hand pieces with 420 - 1050 nm wavelengths, with and without contact cooling, is indicated for, but not limited to:
- Hair removal and Permanent Hair Reduction in all skin types (1-VI) to the Fitzpatrick scale
- Recommended wavelengths in the range of 670-1050 nm, 755-950 nm or 580-1050 nm
- Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale
- Recommended wavelength in the range of 515-950 nm
- Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale
- Recommended wavelength in the range of 420-950 nm
- Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (1-VI) to the Fitzpatrick scale
- Recommended wavelength in the range of 560-950 nm
Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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