Who is the manufacturer of LED Eye Perfector, model: EY-36A, EY-36B?

Light Tree Ventures Europe B.V. filed the 510(k) submission for LED Eye Perfector, model: EY-36A, EY-36B (K221444).

What is the FDA product code for LED Eye Perfector, model: EY-36A, EY-36B?

OHS. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for LED Eye Perfector, model: EY-36A, EY-36B?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LED Eye Perfector, model: EY-36A, EY-36B?

dpl® SpectraLite (K171386); RED Light Device (K162489).

Who can help prepare an FDA 510(k) submission like LED Eye Perfector, model: EY-36A, EY-36B?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LED Eye Perfector, model: EY-36A, EY-36B

K221444 · Light Tree Ventures Europe B.V. · OHS · Dec 8, 2022 · General, Plastic Surgery

Device Facts

Record ID	K221444
Device Name	LED Eye Perfector, model: EY-36A, EY-36B
Applicant	Light Tree Ventures Europe B.V.
Product Code	OHS · General, Plastic Surgery
Decision Date	Dec 8, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.

Device Story

LED Eye Perfector (models EY-36A, EY-36B) is an OTC light-emitting diode (LED) device for periorbital wrinkle treatment. Device consists of main unit, charging base, USB cord, velcro straps, and goggles. Emits light at specific wavelengths (EY-36A: 605, 633, 660, 830 nm; EY-36B: 605, 625, 660, 880 nm) using 40 LEDs to provide ~65 mW/cm² irradiance. User wears device over eye area; treatment duration is 3 minutes with automatic shut-off. Device intended for home use by consumers. Output affects skin via photobiomodulation to reduce wrinkles. Benefits include non-invasive, self-administered aesthetic treatment.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance verified via testing to standards including ANSI AAMI ES60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-1-2, IEC 60601-1-6, IEC 62471, IEC 62133-2, ISO 10993-5, and ISO 10993-10.

Technological Characteristics

LED-based light therapy device. 40 LEDs; irradiance ~65 mW/cm². Powered by 3.7V 420mAh lithium battery. Biocompatible materials per ISO 10993-5/10. Safety compliance: IEC 60601-1, IEC 60601-2-57, IEC 62471. Form factor: wearable eye device with straps and goggles.

Indications for Use

Indicated for individuals with wrinkles within the periorbital region for OTC use.

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

dpl® SpectraLite (K171386)
RED Light Device (K162489)

Related Devices

K233556 — LED Eye mask (EY-20R, A20, EY-20N) · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Jan 4, 2024
K062991 — GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE · Light Bioscience, LLC · Feb 15, 2008
K141181 — NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES · Led Technologies, LLC · Mar 31, 2015
K092800 — ANTI-WRINKLE (AGING) LIGHT, MODEL AAL · Led Intellectual Properties, LLC · Feb 4, 2010
K120775 — LIGHT FOR WRINKLES · Led Intellectual Properties, LLC · Jun 4, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 8, 2022 Light Tree Ventures Europe B.V. Kim Laurens Manager Laan van Ypenburg 108, 2497 GC The Hague, Netherlands Re: K221444 Trade/Device Name: LED Eye Perfector, model: EY-36A, EY-36B 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: November 10, 2022 Received: November 10, 2022 Dear Kim Laurens: 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 text "Jianting Wang -S" in a large, bold font. The text is black and appears to be centered. The background is white, and there is a faint watermark behind the text. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221444 Device Name LED Eye Perfector (Model: EY-36A, EY-36B) Indications for Use (Describe) The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary of K221444 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. #### 1. Submitter's Information Sponsor Name: Light Tree Ventures Europe B.V. Establishment Registration Number: 3017422691 Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: regulation@kaiyanmedical.com #### Distributor Company Name: CurrentBody.com Ltd Address: Unit D6, Stanley Green Business Park, Commercial Avenue, Cheadle Hulme SK8 6QH #### Factory Company Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building 3, No.40, Fuxin street, Huaide Community, Fuyong Town,Baoan District, Shenzhen, Guangdong, 518103, China #### Application Correspondent: Contact Person: Alain Dijkstra Company: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Tel: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com #### 2. Subject Device Information Trade Name: LED Eye Perfector, model: EY-36A, EY-36B Trademark: CurrentBody SkinTM Classification Name: Light Based Over-The-Counter Wrinkle Reduction Review Panel: General & Plastic Surgery Product Code: OHS {4}------------------------------------------------ Regulation Number: 21 CFR 878.4810 Regulation Class: II #### 3. Predicate Device Information Predicate Device (Primary comparison device) Sponsor: LED Technologies, Inc Trade Name: dpl® SpectraLite Classification Name: Light Based Over-The-Counter Wrinkle Reduction Common Name: dpl® SpectraLite 510(K) Number: K171386 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II #### Predicate Device (Second comparison device) Sponsor: Zhongshan Bisen Plastic Electronic Products Co., Ltd. Trade Name: RED Light Device Classification Name: Light Based Over The Counter Wrinkle Reduction Common Name: Light Emitting Diode (LED) Device 510(K) Number: K162489 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II #### 4. Device Description The LED Eye Perfector, model: EY-36A and EY-36B is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat wrinkles within the periorbital region. The device uses four types of LEDs, and for model EY-36A: 605 nm, 633 nm, 660nm, 830 nm, for EY-36B: 605 nm, 625 nm, 660nm, and 880 nm. The treatment time can be controlled by the user, or automatically shut off within a set time. The LED Eye Perfector components contain the main unit device, charging base, USB charging cord, velcro straps and goggles. There is a total of 40 LEDs to provide a power intensity of about 65 mW/cm². The user wears the device on their eye area for the treatment, and the device will shut down automatically after a 3-minute after finishing treatment. {5}------------------------------------------------ There are no differences between the two models other than the output wavelength. #### 5. Intended Use / Indications for Use The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region. #### 6. Comparison to predicate device and conclusion Compare with the predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between the subject device and predicate devices do not raise new questions of safety or effectiveness. | Elements of Comparison | Subject Device | Predicate Device (Primary comparison device) | Predicate Device (Second comparison device) | Remark | | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------| | Company | Light Tree Ventures Europe B.V. | LED Technologies, Inc | Zhongshan Bisen Plastic Electronic Products Co., Ltd. | -- | | | Trade Name | LED Eye Perfector | dpl® SpectraLite | RED Light Device | -- | | | Model | EY-36A EY-36B | EY-40 | BZ-0606 | -- | | | Classification Name | Light Based Over-The- Counter Wrinkle Reduction | Light Based Over- The-Counter Wrinkle Reduction | Light Based Over The Counter Wrinkle Reduction | Same | | | 510(k) Number | Applying | K171386 | K162489 | -- | | | Product Code | OHS | OHS | OHS | Same | | | Intended Use / Indications for Use | The LED Eye Perfector (Model: EY-36A, EY- 36B) is an Over-the- Counter (OTC) device intended for use in treating wrinkles within the periorbital region. | The dpl® SpectraLite is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the | The RED Light Device is an OTC device indicated to emit energy in the red and IR region of the spectrum for | Same | | | | | | periorbital region. | use in dermatology for the treatment of periorbital wrinkles. | | | Power Supply | Main unit: 3.7V, 420mAh lithium battery, 1.55Wh Adapter Input: 100- 240Va.c., 50/60Hz Adapter Output: 5Vd.c, 1A | | 120-240V 5VDC Power Adapter | Adaptor:100~24 0V AC 50/60Hz Lithium battery: 2x3.7V | Similar Note 1 | | Wavelengths | 605 nm, 633 nm, 660nm, 830 nm | 605 nm, 625 nm, 660nm, 880 nm | 605 nm, 625 nm, 660nm, 880 nm | Red: 633 ±5nm Infrared: 830 ±5nm | Similar Note 2 | | Modes | On/Off | | On/Off | Not applicable | Same | | Irradiance source | LED | | LED | LEDs | Same | | Visible light LEDs | Yes | | Yes | Yes | Same | | Treatment Area | 40 cm² | | 28 cm² | 17cm² | Different Note 2 | | Energy Level | 65 mW/cm² | | 61.59 mW/cm² | 125 mW/cm² 70 mW/cm² (633 nm); 55 mW/cm² (830 nm) | Different Note 2 | | LED distribution | Uniform distribution | Uniform distribution | Uniform distribution | No publicity | Same | | Treatment Time | 3 minutes per treatment | | 3 minutes per treatment | For the first month (4 weeks), treatment should be performed 3 times a week for 15-20 minutes | Same | | | | | each time. (5-7 minutes on each treatment zone). | | | | Target Population | Individuals with wrinkles on their face within the periorbital region. | Individuals with wrinkles on their face within the periorbital region. | Individuals with periorbital lines and wrinkles | Same | | | Location for USE | OTC | OTC | OTC | Same | | | EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same | | | Safety | IEC 60601-1 IEC 60601-2-57 IEC 60601-1-11 IEC 62471 | IEC 60601-1, IEC 62471 | IEC 60601-1 IEC 60601-2-57 IEC 60601-1-11 IEC 62471 | Same | | | Biocompatibility | ISO 10993-1 ISO 10993-5 ISO 10993-10 | ISO 10993-1, ISO 10993-5, ISO 10993-10 | ISO 10993-1, ISO 10993-5, ISO 10993-10 | Same | | {6}------------------------------------------------ {7}------------------------------------------------ ## Comparison in Detail(s): Note 1: Although the "Power Supply" is a little different from the predicate devices, they all complied with the IEC 60601-1 and IEC 60601-1-2 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issues. Note 2: Although the "Wavelengths", "Treatment Area" and "Energy Level" are a little different from the predicate devices, they all complied with the IEC 60601-1-2, IEC 60601-2-57, and IEC 62471 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issues. ## 7. Test Summary LED Eye Perfector (Model: EY-36A, EY-36B) has been evaluated the safety and performance by lab bench testing as following: | Standards No. | Standard Title | Version | Date | Recognition Number | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------|--------------------| | ANSI AAMI ES60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | 07/09/2014 | 19-4 | | IEC 60601-1-11 | 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 | Edition 2.1 2020-07 | 12/21/2020 | 19-38 | | IEC 60601-2-57 | 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 | Edition 1.0 2011-01 | 03/16/2012 | 12-242 | | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | Edition 4.1 2020-09 | 12/21/2020 | 19-36 | | IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Edition 3.2 2020-07 | 12/21/2020 | 5-132 | | IEC 62471 | Photobiological safety of lamps and lamp systems | First edition 2006-07 | 08/20/2012 | 12-249 | | IEC 62133-2 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 2: Lithium systems | Edition 1.0 2017-02 | 12/23/2019 | 19-33 | | ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Third edition 2009- 06-01 | 12/23/2016 | 2-245 | | ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Third Edition 2010- 08-01 | 07/26/2016 | 2-174 | {8}------------------------------------------------ {9}------------------------------------------------ ## 8. Date of the summary prepared: November 10, 2022 ## 9. Final Conclusion: The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K171386 and K162489.