Q-Rejuvalight Pro Facewear (Model: P19-0023)
Device Facts
| Record ID | K230042 |
|---|---|
| Device Name | Q-Rejuvalight Pro Facewear (Model: P19-0023) |
| Applicant | Light Tree Ventures Europe B.V. |
| Product Code | OHS · General, Plastic Surgery |
| Decision Date | Apr 28, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Q-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
Device Story
Q-Rejuvalight Pro Facewear is an OTC LED-based mask for facial skin treatment. Device emits specific wavelengths (415nm, 605nm, 630nm, 660nm, 880nm) to treat wrinkles and mild to moderate inflammatory acne. User applies mask directly to face; device operates via pre-set 3-minute treatment cycle with automatic shut-off. Powered by internal Li-ion battery (3.7V, 600mAh) charged via USB. No user-serviceable parts. Output is light energy; healthcare provider/patient uses device to potentially improve skin appearance and reduce acne inflammation. Device is intended for home use.
Clinical Evidence
Bench testing only. No clinical data provided. Safety and performance evaluated via electrical safety (IEC 60601-1, 60601-1-11, 60601-1-2, 60601-2-57), battery safety (IEC 62133-2), photobiological safety (IEC 62471), and biocompatibility (ISO 10993-5, 10993-10, 10993-23).
Technological Characteristics
LED-based light therapy device. Wavelengths: 415nm, 605nm, 630nm, 660nm, 880nm. Power source: 3.7V Li-ion battery, USB rechargeable. Form factor: wearable face mask. Biocompatibility per ISO 10993. Safety compliance: IEC 60601-1, 60601-1-11, 60601-1-2, 60601-2-57, IEC 62471.
Indications for Use
Indicated for treatment of wrinkles and mild to moderate inflammatory acne in the general population.
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
Submission Summary (Full Text)
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April 28, 2023
Light Tree Ventures Europe B.V. Alain Dijkstra Manager Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Hague, Netherlands
Re: K230042
Trade/Device Name: Q-Rejuvalight Pro Facewear (Model: P19-0023) 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. OLP Dated: February 27, 2023 Received: February 27, 2023
Dear Alain Dijkstra:
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
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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,
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) K230042
Device Name
Q-Rejuvalight Pro Facewear (Model: P19-0023)
Indications for Use (Describe)
The O-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
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) Summary of K230042
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
## 1. Date of the summary prepared: April 3, 2023
## 2. Submitter's Information
Company Name: Light Tree Ventures Europe B.V. 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
## Manufacture
Company Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China
#### Distributor
Company Name: Qure Skincare Pty Ltd Address: Level 1, 56 Clarence street NSW2000 Sydney Australia
#### Application Correspondent
Contact Person: Mr. Alain Dijkstra Company Name: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Tel: +86-135-10378748 Fax: +86-755-25024651 Email: regulation@kaiyanmedical.com
## 3. Subject Device Information
Type of 510(k): Traditional Classification Name: Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP) Trade Name: Q-Rejuvalight Pro Facewear
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Model Name: P19-0023 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810 Regulatory Class: II
#### 4. Predicate Device Information
Predicate Device 1: Sponsor: LED Technologies, Inc. Trade Name: dpl® Faceware Classification Name: Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP) 510(k) Number: K183247 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 21 CFR 878.4810 Regulation Class: II
## Predicate Device 2:
Sponsor: Light Tree Ventures Europe B.V. Trade Name: LUSTRE ClearSkin Renew Pro Facewear Mask Classification Name: Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP) 510(k) Number: K230124 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 21 CFR 878.4810 Regulation Class: II
## Predicate Device 3:
Sponsor: LED Technologies, Inc. Trade Name: dpl® II Panel Classification Name: Light Based Over The Counter Wrinkle Reduction (OHS) 510(k) Number: K171390 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810
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Regulation Class: II
## 5. Device Description
The Q-Rejuvalight Pro Facewear is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. The device uses four types of LEDs for Wrinkles: 605nm, 660nm, and 880nm and two types of LEDs for Acne: 415nm and 630nm. Each mode takes 3 minutes (±3s) for a course of treatment, and the mask will automatically turn off at the end of time.
The Q-Rejuvalight Pro Facewear components include the main device, head strap, eye rest, Latch, User Manual, Storage bag and USB power cord.
The Q-Rejuvalight Pro Facewear is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
## 6. Intended Use / Indications for Use
The Q-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
## 7. Test Summary
Q-Rejuvalight Pro Facewear (Model: P19-0023) has been evaluated the safety and performance by lab bench testing as following:
| Standard<br>No. | Standards Title | Version | Date |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------|
| ANSI AAMI<br>ES60601-1 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance (IEC 60601-1:2005, MOD) | 2005/(R)2012 & A1:2012,<br>C1:2009/(R)2012 &<br>A2:2010/(R)2012 (Cons.<br>Text) [Incl. AMD2:2021] | 05/30/2022 |
| IEC 60601-<br>1-11 | Medical Electrical Equipment -- Part 1-11:<br>General requirements for basic safety and<br>essential performance -- Collateral Standard:<br>Requirements for medical electrical equipment<br>and medical electrical equipment and medical<br>electrical systems used in the home healthcare<br>environment (IEC 60601-1-11:2015 MOD) | Edition 2.1 2020-07<br>CONSOLIDATED<br>VERSION | 12/21/2020 |
| IEC 60601-<br>1-2 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral Standard: | Edition 4.0 2014-02 | 09/17/2018 |
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| Standard<br>No. | Standards Title | Version | Date |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------|
| | Electromagnetic disturbances - Requirements<br>and tests | | |
| IEC 60601-<br>2-57 | Medical Electrical Equipment - Part 2-57:<br>Particular requirements for the basic safety and<br>essential performance of non-laser light source<br>equipment intended for therapeutic, diagnostic,<br>monitoring and cosmetic/aesthetic use | Edition 1.0 2011-01 | 03/16/2012 |
| IEC 62133-<br>2 | Secondary cells and batteries containing alkaline<br>or other non-acid electrolytes - Safety<br>requirements for portable sealed secondary cells,<br>and for batteries made from them, for use in<br>portable applications - Part 2: Lithium systems | Edition 1.0 2017-02 | 12/23/2019 |
| IEC 62471 | Photobiological safety of lamps and lamp systems | First edition 2006-07 | 08/20/2012 |
| ISO<br>10993-5 | Biological evaluation of medical devices - Part 5:<br>Tests for in vitro cytotoxicity | Third edition 2009-06-01 | 12/23/2016 |
| ISO<br>10993-10 | Biological evaluation of medical devices - Part 10:<br>Tests for irritation and skin sensitization | Fourth edition 2021-11 | 12/19/2022 |
| ISO<br>10993-23 | Biological evaluation of medical devices - Part 23:<br>Tests for irritation | First edition 2021-01 | 06/07/2021 |
## 8. Comparison to predicate device
| Elements of<br>Comparison | Subject<br>Device | Predicate<br>Device 1<br>(Primary) | Predicate<br>Device 2<br>(Reference) | Predicate<br>Device 3<br>(Reference) | Remark |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------|
| Company | Shenzhen<br>Kaiyan Medical<br>Equipment Co.,<br>Ltd | LED<br>Technologies,<br>Inc. | Light Tree<br>Ventures<br>Europe B.V. | LED<br>Technologies,<br>Inc. | -- |
| Trade Name | Q-Rejuvalight<br>Pro Facewear | dpl® Faceware | LUSTRE<br>ClearSkin<br>Renew Pro<br>Facewear<br>Mask | dpl® II Panel | -- |
| Classification<br>Name | Light Based<br>Over The<br>Counter<br>Wrinkle<br>Reduction(OH<br>S), Over-The-<br>Counter<br>Powered | Light Based<br>Over The<br>Counter<br>Wrinkle<br>Reduction(OH<br>S), Over-The-<br>Counter<br>Powered Light | Light Based<br>Over The<br>Counter<br>Wrinkle<br>Reduction(OH<br>S), Over-The-<br>Counter<br>Powered Light | Light Based<br>Over The<br>Counter<br>Wrinkle<br>Reduction<br>(OHS) | -- |
| Elements of<br>Comparison | Subject<br>Device | Predicate<br>Device 1<br>(Primary) | Predicate<br>Device 2<br>(Reference) | Predicate<br>Device 3<br>(Reference) | Remark |
| | Light Based<br>Laser For<br>Acne (OLP) | Based Laser<br>For Acne(OLP) | Based Laser<br>For Acne(OLP) | | |
| 510(k) Number | K230042 | K183247 | K230124 | K171390 | -- |
| Product Code | OHS, OLP | OHS, OLP | OHS, OLP | OLP | Same |
| Intended Use /<br>Indications for<br>Use | The Q-<br>Rejuvalight Pro<br>Facewear<br>(Model: P19-<br>0023) is an<br>Over-the-<br>Counter (OTC)<br>device<br>intended for<br>treatment of<br>wrinkles and<br>mild to<br>moderate<br>inflammatory<br>acne. | The dpl®<br>Faceware is an<br>Over-the-<br>Counter (OTC)<br>LED device<br>intended for<br>use in treating<br>wrinkles and<br>mild to<br>moderate<br>inflammatory<br>acne. | The LUSTRE<br>ClearSkin<br>Renew Pro<br>Facewear<br>Mask is an<br>over-the-<br>counter device<br>intended to<br>emit<br>energy in the<br>red and blue<br>region of the<br>light spectrum,<br>specifically<br>indicated to<br>treat mild to<br>moderate acne<br>vulgaris of the<br>face.<br>The LUSTRE<br>ClearSkin<br>Renew Pro<br>Facewear<br>Mask is an<br>over-the-<br>counter device<br>intended to<br>emit<br>energy in the<br>red and Near<br>Infra-red<br>spectrum and<br>is intended for<br>the use in the<br>treatment of<br>full-face<br>wrinkles. | The dpl® II<br>Panel is an<br>Over-the-<br>Counter (OTC)<br>device<br>intended for<br>use in treating<br>wrinkles. | Same |
| Power source | Input: 5V,<br>50/60Hz, 2A<br>Li-ion Polymer<br>Battery: 3.7V,<br>600mAh,<br>2.22Wh | Li-ion Battery<br>5V USB & 3.7<br>V Battery | Lithium battery:<br>3.7V, 1500mAh<br>5.55Wh<br>Adapter Input:<br>100-240Va.c.,<br>50/60Hz<br>Adapter<br>Output: 5Vd.c.,<br>1 A | 120-240V AC<br>Power Adapter | Similar<br>Note 1 |
| Elements of<br>Comparison | Subject<br>Device | Predicate<br>Device 1<br>(Primary) | Predicate<br>Device 2<br>(Reference) | Predicate<br>Device 3<br>(Reference) | Remark |
| Wavelengths | 605nm,<br>630nm,<br>660nm,<br>880nm,<br>415nm | 605nm,<br>630nm,<br>660nm,<br>880nm,<br>415nm | Red: 630±5nm<br>Blue: 415±5nm<br>NIF: 830±5nm | 605nm,<br>630nm,<br>660nm, 880nm | Same |
| Power Density | Single<br>wavelength:<br>605nm:<br>15±5mW/cm²<br>630nm:<br>20±5mW/cm²<br>660nm:<br>25±5mW/cm²<br>880nm:<br>10±5mW/cm²<br>415nm:<br>25±5mW/cm²<br>Total:<br>70mW/cm²(wri<br>nkle)<br>45mW/cm²(acn<br>e) | No publicly<br>available | Red: 18<br>mw/cm²<br>NIR: 12<br>mw/cm²<br>Total: 30<br>mw/cm²(wrinkl<br>e)<br>Blue: 26<br>mw/cm²<br>Red: 16<br>mw/cm²<br>Total: 42<br>mw/cm² (acne) | Total:<br>70.16mW/cm²(<br>wrinkle) | Similar<br>Note 2 |
| Irradiance<br>source | LEDs | LEDs | LEDs | LEDs | Same |
| Total Number<br>of LEDs | 80pcs | No publicly<br>available | 80pcs | No publicly<br>available | Same |
| LED<br>Distribution | 630nm+415nm<br>(Double wick):<br>30pcs<br>630nm+605nm<br>(Double wick):<br>25pcs<br>660nm+880nm<br>(Double wick):<br>25pcs | No publicly<br>available | 630nm+415nm<br>(Double wick):<br>30pcs<br>630nm+830nm<br>(Double wick):<br>50pcs | 630nm+830nm<br>(Double wick):<br>50pcs | Similar<br>Note 4 |
| Treatment area | 81(acne)<br>140(wrinkle) | 81(acne)<br>135.8(wrinkle) | No publicly<br>available | 415cm² | Same |
| Treatment time | 3 minutes per<br>treatment | 3 minutes per<br>treatment | 10 minutes | 3 minutes per<br>treatment | Same |
| Location for<br>Use | Face | Face | Face | Face | Same |
| Environment of<br>Use | OTC | OTC | OTC | OTC | Same |
| Safety and<br>EMC | IEC 60601-1<br>IEC 60601-1-<br>11<br>IEC 60601-1-2<br>IEC 60601-2-<br>57<br>IEC 62133-2 | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-<br>11<br>IEC 60601-1-2<br>IEC 60601-2-<br>57<br>IEC 62133-2 | IEC 60601-1<br>IEC 60601-1-2 | Similar<br>Note 3 |
| Elements of<br>Comparison | Subject<br>Device | Predicate<br>Device 1<br>(Primary) | Predicate<br>Device 2<br>(Reference) | Predicate<br>Device 3<br>(Reference) | Remark |
| | IEC 62471 | | IEC 62471 | | |
| Biocompatibility | ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23 | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23 | ISO 10993-10 | Same |
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## Comparison in details:
## Note 1:
The description in "Power supply" of the subject device is slightly different from the predicate device, both of them use a Lithium-lon battery and are charged by the 5V USB. Besides, both the subject device and the predicate conducted the safety test according to the IEC 60601 series standards, and the test results are in compliance with safety standards' requirements. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
## Note 2:
Although there is no detailed information on the "Power Density" for each wavelength of predicate devices available, both the subject device and predicate device 3 have the same treatment wavelengths (605nm+630nm+660nm+880nm) and total power density designed in treating the wrinkles, both of the subject device and predicate device 2 have the same treatment wavelengths (630nm+415nm) and similar total power density designed in treating the acne. So, the slight difference between the subject device and the predicate devices will not raise any safety or effectiveness issues.
#### Note 3:
The description in "Safety and EMC" of the subject device is slightly different from the predicate device, both the subject device and the predicate conducted the electrical safety and electromagnetic compatibility tests according to the international series standards, and the test results are in compliance with standards' requirements. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
## Note 4:
Although the "LED Distribution" of the subject device is slightly different from the predicate devices, the subject device has the same/similar treatment parameters such as the treatment wavelengths and power density designed with the predicate devices. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
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## 9. Final Conclusion
The subject device Q-Rejuvalight Pro Facewear (Model: P19-0023) is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K183247, K230124 and K171390.
