(107 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on IPL technology and basic sensors.
No
The device is intended for cosmetic purposes (hair removal and reduction in hair regrowth) and does not treat or diagnose a disease or condition.
No
The device is intended for hair removal and permanent hair regrowth reduction, which are cosmetic and treatment-oriented functions, not diagnostic.
No
The device description explicitly states it is a "light-based device" utilizing "IPL technology" and contains a "Xenon Lamp" and a "skin contact sensor," indicating it is a hardware device with physical components for delivering treatment.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Diamond Air+ Function: The Diamond Air+ is a light-based device that uses IPL technology to remove hair and reduce hair regrowth. It works by applying light energy directly to the skin to target hair follicles. This is a physical interaction with the body's surface, not an analysis of a biological specimen.
- Intended Use: The intended use clearly states "removal of unwanted body and/or facial hair" and "permanent reduction in hair regrowth." This is a cosmetic or aesthetic application, not a diagnostic one.
The information provided describes a device that interacts with the body's surface for a cosmetic purpose, which is fundamentally different from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs recrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Product codes
OHT
Device Description
Diamond Air+ (Model: UI04A, UI04B, UI04C) is a light-based device for long-term hair removal intended to be sold over-the-counter directly to the end user. The subject device is identical to that cleared via K213558.
It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device utilizes the IPL technology with 5 Levels of output energy.
The size of the device is 6038169.86mm (W x D x H). It contains a Xenon Lamp and a skin contact sensor to detect appropriate skin application. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with not start treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
IPL (Intense Pulsed Light)
Anatomical Site
body and/or facial hair, underarms, bikini line, arms and legs.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter device intended to be sold over-the-counter directly to the end user.
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 new clinical performance data is reported in this submission.
Human Factors testing was conducted to support the subject device's OTC indication for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 15, 2022
Ulike Co., Ltd % Sun Cindy Senior Consultant PureVision Ai, Inc. 111 Town Square Place, Suite 1203 New Jersey, New Jersey 07310
Re: K221553
Trade/Device Name: Diamond Air+ (UI04A, UI04B, UI04C) 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: OHT Dated: May 31, 2022 Received: May 31, 2022
Dear Sun Cindy:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Diamond Air+ (UI04A, UI04B, UI04B, UI04C)
Indications for Use (Describe)
Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the longterm. stable reduction in the number of hairs recrowing when measured at 6, 9 and 12 months after the completion of a treatment regime ..
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) #: | K221553 | 510(k) Summary | Prepared on: 2022-09-15 |
|---|---|---|---|
| ----------- | --------- | ---------------- | ------------------------- |
21 CFR 807.92(a)(1)
| Contact Details |
|---|
| ----------------- |
| Applicant Name | Ulike Co., Ltd |
|---|---|
| Applicant Address | 2, Myeongdong, 6-gil, Jung-gu Seoul 04535 Korea, South |
| Applicant Contact Telephone | +8615915373017 |
| Applicant Contact | Ms. Lin Xiaoming |
| Applicant Contact Email | rd5@ulikebeauty.com |
21 CFR 807.92(a)(2)
| Device Name |
|---|
| ------------- |
| Device Trade Name | Diamond Air+ (UI04A, UI04B, UI04C) |
|---|---|
| Common Name | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Classification Name | Light Based Over-The-Counter Hair Removal |
| Regulation Number | 878.4810 |
| Product Code | OHT |
21 CFR 807.92(a)(3)
| Legally Marketed Predicate Devices |
|---|
| ------------------------------------ |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K213558 | IPL Hair Removal Device | ONF |
| K192432 | IPL Home Use Hair Removal Device | OHT |
21 CFR 807.92(a)(4)
| Device Description Summary |
|---|
| ---------------------------- |
Diamond Air+ (Model: UI04A, UI04B, UI04C) is a light-based device for long-term hair removal intended to be sold over-the-counterDiamond Air+ (Model: U04A, U04C) is a light-based device for long-term hair removal intended to be sold over-the-counter directly to the end user. The subject device is identical to that cleared via K213558.
It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device utilizes the IPL technology with 5 Levels of output energy.
The size of the device is 6038169.86mm (W x D x H). It contains a Xenon Lamp and a skin contact sensor to detect appropriate skin application. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with not start treatment.
Intended Use/Indications for Use
Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, 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 regime.
Indications for Use Comparison
The indications for use are the same for the submitted device and the predicate devices.
21 CFR 807.92(a)(5)
e underarms
e device is also indicated for
21 CFR 807.92(a)(5)
4
The technological characteristics, features, materials, and intended use of submitted device is substantially equivalent to the predicate devices quoted above.
The differences between the subject devices do not raise new issues of safety or effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
No new clinical performance data is reported in this submission.
Human Factors testing was conducted to support the subject device's OTC indication for use.