(266 days)
Not Found
Not Found
No
The provided text describes a laser device for hair removal and skin treatments, focusing on wavelengths and indications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is indicated for use in medical specialties for conditions like pseudofolliculitis barbae and the removal of benign vascular lesions, which are therapeutic applications.
No
The device is indicated for aesthetic applications and specific medical treatments like hair removal, pseudofolliculitis barbae treatment, and removal of lesions, which are all therapeutic or cosmetic procedures, not diagnostic ones.
No
The intended use and indications for use clearly describe a laser device with specific wavelengths (760 nm, 808 nm, 1060 nm) and a handpiece. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes aesthetic and medical treatments performed on the patient's body (hair removal, treatment of skin conditions, coagulation of lesions). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: While the description is "Not Found," the intended use strongly suggests a device that interacts directly with the patient's skin, not a laboratory instrument for analyzing samples.
- Lack of IVD-related terms: There is no mention of analyzing biological samples, diagnostic testing, or any other activities typically associated with IVDs.
Therefore, the EPILDREAM HP 4000 MED is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
EPILDREAM HP 4000 MED is indicated for: use in aesthetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.
760 nm wavelength laser is indicated for : Hair removal, permanent hair reduction* 808 nm wavelength laser is indicated for : Hair removal, permanent hair reduction* 1060 nm wavelength laser is indicated for:
- · Treatment of pseudofolliculitis barbae (PFB)
- · Hair removal, permanent hair reduction*
*Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The handpiece which uses three wavelengths simultaneously is indicated for use in dermatology procedures requiring coagulation, and for the removal of benign vascular and vascular dependent lesions.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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)
Not Found
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 27, 2023
D.E.A Project S.r.1. % Chiara Violini Consultant Endo Engineering Via Del Consorzio, 41 Falconara Marittima, AN 60015 Italy
Re: K222352
Trade/Device Name: Epildream HP 4000 MED 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: March 17, 2023 Received: March 17, 2023
Dear Chiara Violini:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, clear font. The text is black and stands out against a light background. The name appears to be written in a simple, sans-serif typeface, making it easily readable.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K22352
Device Name EPILDREAM HP 4000 MED
Indications for Use (Describe)
EPILDREAM HP 4000 MED is indicated for: use in aesthetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.
760 nm wavelength laser is indicated for : Hair removal, permanent hair reduction* 808 nm wavelength laser is indicated for : Hair removal, permanent hair reduction* 1060 nm wavelength laser is indicated for:
- · Treatment of pseudofolliculitis barbae (PFB)
- · Hair removal, permanent hair reduction*
*Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The handpiece which uses three wavelengths simultaneously is indicated for use in dermatology procedures requiring coagulation, and for the removal of benign vascular and vascular dependent lesions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED |
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