easy Claire

K223278 · Y & J Bio Co., Ltd. · OHS · Nov 17, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K223278
• Device Name: easy Claire
• Applicant: Y & J Bio Co., Ltd.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Nov 17, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The easy Claire is an over-the-counter medical device intended for the use in the treatment of full face wrinkles.

Device Story

Lightweight mask device for home use; emits 630nm LED and 850nm IRED light to induce photobiological effects for facial wrinkle reduction. User operates via touch switch; device features protective eye-shield to prevent ocular irradiation; automatic shut-off after 9-minute treatment cycle. Powered by internal rechargeable lithium-ion battery. Output consists of light energy at 20±20% mW/cm² total intensity and 10.8±20% J/cm² dose. Benefits patient by providing non-invasive cosmetic wrinkle treatment.

Clinical Evidence

Bench testing only. Safety and effectiveness demonstrated via compliance with IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 60601-1-11 (home healthcare), IEC 60601-2-57 (non-laser light source), IEC 62471 (photobiological safety), ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation/sensitization). Risk management conducted per ISO 14971.

Technological Characteristics

Mask form factor; 99 LEDs (630nm) and 99 IREDs (850nm); power 20±20% mW/cm²; dose 10.8±20% J/cm²; internal rechargeable lithium-ion battery; external adapter (AC 100-240V, 50/60Hz; DC 5V, 2A). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-57, IEC 62471, ISO 10993-5, ISO 10993-10, ISO 14971.

Indications for Use

Indicated for the treatment of full face wrinkles in adult patients using an over-the-counter device.

Regulatory Classification

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.

Predicate Devices

• easy Claire (K213285)

Submission Summary (Full Text)

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November 17, 2022

Y&J BIO Co., Ltd. % Paweena U-Thainual CEO MDR Solutions Co., Ltd. 1435 Kanjanapisek Rd., Bang Khae Nuea Bang Khae, Bangkok 10160 Thailand

Re: K223278

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: October 18, 2022 Received: October 24, 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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Jianting Wang -S

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

510(k) Number (if known) K223278

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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## 5. 510(k) Summary

### 1. General Information

| Applicant/Submitter: | Y&J BIO Co., Ltd. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | B-916 ,947, Hanam-daero, Hanam-si,<br>Gyeonggi-do, Republic of Korea<br>Tel) [phone] |
| Contact Person:<br>Address: | Paweena U-Thainual, PhD<br>MDR Solutions Co., Ltd.<br>1435 Kanjanapisek Rd., Bang Khae Nuea<br>Bang Khae, Bangkok, 10160 THAILAND<br>Tel: [phone]<br>Email: [e-mail] |
| Preparation Date: | October 18, 2022 |

## 2. Device Name and Code

| Device Trade Name: | easy Claire |
|----------------------|------------------------------------------------|
| 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 |
|-------------------|-------------|---------------|
| Y&J BIO Co., Ltd. | easy Claire | K213285 |

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#### 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 full face wrinkles.

#### 6. Technical Characteristics in Comparison to Predicate Devices

easy Claire is substantially equivalent to the following legally marketed predicate devices.

| | Proposed Device | Predicate Device<br>K213285 | Equivalence<br>(Y/N) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Company | Y&J BIO Co., Ltd. | Y&J BIO Co., Ltd. | Y |
| Product name | easy Claire | easy Claire | Y |
| Product code | OHS | OHS | Y |
| Regulation<br>number | 878.4810 | 878.4810 | Y |
| Classification | Class II | Class II | Y |
| Intended<br>Use | The easy Claire is an over-<br>the-counter medical device<br>intended for the use in the<br>treatment of full face<br>wrinkles. | The easy Claire is an over-<br>the-counter medical device<br>intended for the use in the<br>treatment of full face<br>wrinkles. | Y |
| Type of use | OTC | OTC | Y |
| Technological<br>characteristics | | | Y |
| Wavelength | RED(630nm)<br>IR(850nm) | RED(630nm)<br>IR(850nm) | Y |
| LED power | $20\pm20\%$ mW/cm² total | $20\pm20\%$ mW/cm² total | Y |
| Treatment<br>time | 9 minutes everyday per week<br>for 8 weeks. | 9 minutes everyday per week<br>for 8 weeks. | Y |

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#### easy Claire 510(k) Summary

| Standard dose<br>in Joules | $10.8\pm20\% J/cm^2$ | $10.8\pm20\% J/cm^2$ | Y |
|----------------------------|----------------------|----------------------|---|
|----------------------------|----------------------|----------------------|---|

#### 6. 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, 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.

#### 7. Substantial Equivalence

The intended use of the easy Claire is identical to the 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 usage of its underlying technological principles between easy Claire and the cited predicate devices.

#### 8. 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.