(153 days)
No
The device description focuses on the physical components and light emission technology, with no mention of AI or ML capabilities. The summary also explicitly states "Not Found" for mentions of AI, DNN, or ML, and descriptions of training/test sets.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the treatment of full face wrinkles." Treatment is a function of therapeutic devices.
No
Explanation: The device is intended for the "treatment of full face wrinkles" using LED and IRED light and does not mention any diagnostic capabilities.
No
The device description explicitly details hardware components such as LEDs, IREDs, a mask, a touch switch button, an eye-shield, and a rechargeable battery, indicating it is a physical device, not software-only.
Based on the provided information, the easy Claire device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of full face wrinkles." This is a therapeutic application, not a diagnostic one.
- Device Description: The device uses LED and IRED light to induce "photobiological effects for the treatment of facial wrinkles." This describes a physical intervention on the body, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The easy Claire does not perform any such tests.
The easy Claire is a light therapy device intended for direct application to the skin for therapeutic purposes.
N/A
Intended Use / Indications for Use
The easy Claire is an over-the-counter medical device intended for the treatment of full face wrinkles.
Product codes
OHS
Device Description
The easy Claire is a device that allows the emission of 630nm LED light and 850nm IRED light on the face, which induces photobiological effects for the treatment of facial wrinkles. The easy Claire is an over-the-counter device and consists of a collection of 99 LEDs (630nm) and 99 IREDs (850nm) for the treatment of facial wrinkles. Users place the lightweight mask over the face and use the touch switch button to operate the easy Claire. The device will automatically turn off after treatment. To prevent irradiation of LED lights to the eye during the treatment, easy Claire has a protective eye-shield that blocks light from LEDs. The device is powered by the internal rechargeable lithium-ion battery which is recharged by the specified external adapter with Input AC 100-240V, 50/60Hz, and Output DC 5V, 2A.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
full face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter Use
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)
Non-clinical tests: In order to demonstrate the safety and effectiveness of easy Claire, various test has been conducted using following consensus standards:
- IEC 60601-1:2005, Medical Electrical Equipment Part 1: General Requirements For Basic - Safety And Essential Performance.
- IEC 60601-1-2: 2014, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances.
- -IEC 60601-1-6:2010, AMD1:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- IEC 60601-1-11:2015, Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601- 2-57:2011, Medical Electrical Equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
- IEC 62471:2006, Photobiological safety of lamps and lamp systems is evaluated according to -FDA-recognized consensus standard.
- -ISO 10993-5: 2009, Tests for in vitro cytotoxicity
- -ISO 10993-10: 2010. Tests for irritation and skin sensitization
- Risk management was recorded by referring to ISO 14971:2007.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 3, 2022
Y & J Bio Co., Ltd. % Paweena U-Thainual CEO MDR Solutions Co., Ltd. 1435 Kanchanapisek Rd., Bang Khae Nuea Bang Khae, Bangkok 10160 Thailand
Re: K213285
Trade/Device Name: easy Claire 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: OHS Dated: February 14, 2022 Received: February 16, 2022
Dear Paweena U-Thainual:
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.
1
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); 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 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.
Purva Pandya 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
2
Indications for Use
510(k) Number (if known)
Device Name easy Claire
Indications for Use (Describe)
The easy Claire is an over-the-counter medical device intended for the treatment of full face wrinkles.
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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3
5. 510(k) Summary
1. General Information
| Applicant/Submitter: | Y&J BIO Co., Ltd. |
|---|---|
| Address: | B-916 ,947, Hanam-daero, Hanam-si, |
| Gyeonggi-do, Republic of Korea | |
| Tel) +82-31-5180-3490 | |
| Contact Person: | Paweena U-Thainual, PhD |
| Address: | MDR Solutions Co., Ltd. |
| 1435 Kanjanapisek Rd., Bang Khae Nuea | |
| Bang Khae, Bangkok, 10160 THAILAND | |
| Tel: +662-804-2101 | |
| Email: paweena@mdrsolutions.co.th |
February 11, 2022
2. Device Name and Code
Preparation Date:
| Device Trade Name: | easy Claire |
|---|---|
| Common Name: | Light-based mask |
| Classification Name: | Light Based Over The Counter Wrinkle Reduction |
| Product Code: | OHS |
| Regulation Number: | 878.4810 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery |
3. Predicate Devices
easy Claire is substantially equivalent to the following device: Table 5.1 Predicate devices
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Trophy Skin, Inc. | Rejuvalite MD | K133896 |
Table 5.2 Reference device
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Pulsaderm LLC | Pulsaderm Wrinkle Mask 28 and Wrinkle Mask 72 | K163329 |
4
4. Device Description
The easy Claire is a device that allows the emission of 630nm LED light and 850nm IRED light on the face, which induces photobiological effects for the treatment of facial wrinkles. The easy Claire is an over-the-counter device and consists of a collection of 99 LEDs (630nm) and 99 IREDs (850nm) for the treatment of facial wrinkles.
Users place the lightweight mask over the face and use the touch switch button to operate the easy Claire. The device will automatically turn off after treatment. To prevent irradiation of LED lights to the eye during the treatment, easy Claire has a protective eye-shield that blocks light from LEDs.
The device is powered by the internal rechargeable lithium-ion battery which is recharged by the specified external adapter with Input AC 100-240V, 50/60Hz, and Output DC 5V, 2A.
5. Indications / Intended Use
The easy Claire is an over-the-counter medical device intended for the use in the treatment of fullface wrinkles.
6. Technical Characteristics in Comparison to the Predicate and Reference Devices
The easy Claire is substantially equivalent to the following legally marketed predicate devices.
Table 5.3. Side-by-side comparison with the predicate and reference device
| | Proposed Device
K213285 | Predicate Device
K133896 | Reference Device
K163329 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Y&J BIO Co., Ltd. | Trophy Skin, Inc. | Pulsaderm LLC |
| Product name | easy Claire | Rejuvalite MD | Pulsaderm Wrinkle
Mask 28 and Wrinkle
Mask 72 |
| Product code | OHS | OHS | OHS |
| Regulation
number | 878.4810 | 878.4810 | 878.4810 |
| Classification | Class II | Class II | Class II |
| Intended Use | The easy Claire is an
over-the-counter
medical device intended
for the use in the
treatment of full face
wrinkles | The Rejuvalite MD is an
Over-the-Counter device
that is intended for the
use in the treatment of
full face wrinkles. | The Pulsaderm Wrinkle
Masks 28 and 72 are
intend for the use in the
treatment of facial
wrinkles and for people
with Fitzpatrick Skin
Types I, II and III |
| Type of use | OTC | OTC | OTC |
| Technological
characteristics | | | |
| Wavelength | RED(630nm) | RED(600, 622, 660 nm) | RED(620-630 nm) |
5
easy Claire 510(k) Summary
| IR(850nm) | IR(820nm) | IR(850nm) | |
|---|---|---|---|
| LED power | 20±20% mW/cm² total | 62mW/cm² total | 21.18-25.32mW/cm² total |
| Treatment time | 9 minutes every day for | ||
| 8 weeks | 3 minutes daily 5 days | ||
| per week for 8 weeks | 15 minutes every day | ||
| Standard dose | |||
| in Joules | $10.8\pm20% J/cm²$ | $11.2J/cm²$ | $19J-22.82J/cm²$ |
| Face mask | Yes | No | Yes |
7. Performance Data
Non-clinical tests: In order to demonstrate the safety and effectiveness of easy Claire, various test has been conducted using following consensus standards"
- IEC 60601-1:2005, Medical Electrical Equipment Part 1: General Requirements For Basic - Safety And Essential Performance.
- IEC 60601-1-2: 2014, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances.
- -IEC 60601-1-6:2010, AMD1:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- IEC 60601-1-11:2015, Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601- 2-57:2011, Medical Electrical Equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
- IEC 62471:2006, Photobiological safety of lamps and lamp systems is evaluated according to -FDA-recognized consensus standard.
- -ISO 10993-5: 2009, Tests for in vitro cytotoxicity
- -ISO 10993-10: 2010. Tests for irritation and skin sensitization
- Risk management was recorded by referring to ISO 14971:2007. -
8. Substantial Equivalence
The intended use of the easy Claire is within the scope of the predicate devices. easy Claire, from both a design and clinical perspective, uses similar technology as the cited predicate devices. Based upon the predicted overall performance characteristics for the easy Claire. Y&J BIO Co., Ltd. believes that no significant differences exist in the usage of its underlying technological principles between easy Claire and the cited predicate devices.
9. Conclusions
On the basis of the information provided in this Summary, Y&J BIO Co., Ltd. believes that the easy Claire is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.