(112 days)
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.
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.
The submitted document is a 510(k) summary for the Q-Rejuvalight Pro Facewear. This document primarily focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and conformity to recognized safety and performance standards. It does not contain information about clinical studies with acceptance criteria, reported device performance metrics in relation to those criteria, or details regarding ground truth establishment, sample sizes for test and training sets, expert adjudication, or MRMC studies for this specific device.
The "Test Summary" section lists various safety and performance standards to which the device was evaluated, indicating compliance with these standards for electrical safety, EMC, photobiological safety, and biocompatibility. However, it does not provide acceptance criteria or specific performance results for clinical efficacy of wrinkle reduction or acne treatment.
Therefore, many of the requested details cannot be extracted from this document, as they are not present in a typical 510(k) summary for this type of device. The information provided below is limited to what can be inferred or directly stated from the document regarding technical specifications and safety testing, not clinical effectiveness studies.
Here's the breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria related to efficacy for wrinkle reduction or acne treatment, nor does it provide reported device performance data against such criteria in a clinical context. The "Test Summary" table lists standards for safety and performance (e.g., electrical safety, EMC, photobiological safety, biocompatibility) that the device complies with, but these are not the clinical acceptance criteria you're asking for.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. The document focuses on bench testing and comparison to predicate devices, not clinical trials with test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set with expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a light-emitting therapeutic device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a standalone therapeutic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The ground truth for this medical device clearance is compliance with safety and performance standards and substantial equivalence to legally marketed predicate devices, not clinical efficacy data based on ground truth outcomes for individual patients.
8. The sample size for the training set
Not applicable, as no AI/machine learning training set is mentioned or relevant to this type of device submission.
9. How the ground truth for the training set was established
Not applicable.
Summary based on the provided document:
The Q-Rejuvalight Pro Facewear device has demonstrated compliance with various recognized safety and performance standards through lab bench testing. The 510(k) submission establishes substantial equivalence to predicate devices based on similar intended use, technology (LED-based light therapy), wavelengths, power density (where comparable), treatment time, and environment of use.
The document highlights the following technical characteristics and safety assessments for the Q-Rejuvalight Pro Facewear:
- Intended Use: Treatment of wrinkles and mild to moderate inflammatory acne (OTC device).
- Wavelengths: 605nm, 630nm, 660nm, 880nm (for wrinkles/combination) and 415nm (for acne/combination).
- Power Density:
- Single wavelength: 605nm: 15±5mW/cm², 630nm: 20±5mW/cm², 660nm: 25±5mW/cm², 880nm: 10±5mW/cm², 415nm: 25±5mW/cm²
- Total: 70mW/cm² (wrinkle), 45mW/cm² (acne)
- Treatment Time: 3 minutes per treatment.
- Safety and Performance Standards Compliance (via lab bench testing):
- ANSI AAMI ES60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)
- IEC 60601-1-11 (Requirements for medical electrical equipment in the home healthcare environment)
- IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests)
- IEC 60601-2-57 (Particular requirements for non-laser light source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)
- IEC 62133-2 (Secondary cells and batteries - Safety requirements for lithium systems)
- IEC 62471 (Photobiological safety of lamps and lamp systems)
- Biocompatibility Standards Compliance:
- ISO 10993-5 (Tests for in vitro cytotoxicity)
- ISO 10993-10 (Tests for irritation and skin sensitization)
- ISO 10993-23 (Tests for irritation)
The "Remark" sections (Note 1, 2, 3, 4) in the comparison table explain minor differences between the subject device and predicate devices in terms of power supply, power density details, safety/EMC standards listed, and LED distribution, concluding that these differences "will not raise any safety or effectiveness issues." This implies that the 'acceptance criteria' are met by demonstrating that any differences from the predicate are not significant enough to raise new questions of safety or effectiveness, as demonstrated by compliance with relevant consensus standards.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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:
| StandardNo. | Standards Title | Version | Date |
|---|---|---|---|
| ANSI AAMIES60601-1 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance (IEC 60601-1:2005, MOD) | 2005/(R)2012 & A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012 (Cons.Text) [Incl. AMD2:2021] | 05/30/2022 |
| IEC 60601-1-11 | Medical Electrical Equipment -- Part 1-11:General requirements for basic safety andessential performance -- Collateral Standard:Requirements for medical electrical equipmentand medical electrical equipment and medicalelectrical systems used in the home healthcareenvironment (IEC 60601-1-11:2015 MOD) | Edition 2.1 2020-07CONSOLIDATEDVERSION | 12/21/2020 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard: | Edition 4.0 2014-02 | 09/17/2018 |
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| StandardNo. | Standards Title | Version | Date |
|---|---|---|---|
| Electromagnetic disturbances - Requirementsand tests | |||
| IEC 60601-2-57 | Medical Electrical Equipment - Part 2-57:Particular requirements for the basic safety andessential performance of non-laser light sourceequipment intended for therapeutic, diagnostic,monitoring and cosmetic/aesthetic use | Edition 1.0 2011-01 | 03/16/2012 |
| IEC 62133-2 | Secondary cells and batteries containing alkalineor other non-acid electrolytes - Safetyrequirements for portable sealed secondary cells,and for batteries made from them, for use inportable 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 |
| ISO10993-5 | Biological evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity | Third edition 2009-06-01 | 12/23/2016 |
| ISO10993-10 | Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization | Fourth edition 2021-11 | 12/19/2022 |
| ISO10993-23 | Biological evaluation of medical devices - Part 23:Tests for irritation | First edition 2021-01 | 06/07/2021 |
8. Comparison to predicate device
| Elements ofComparison | SubjectDevice | PredicateDevice 1(Primary) | PredicateDevice 2(Reference) | PredicateDevice 3(Reference) | Remark |
|---|---|---|---|---|---|
| Company | ShenzhenKaiyan MedicalEquipment Co.,Ltd | LEDTechnologies,Inc. | Light TreeVenturesEurope B.V. | LEDTechnologies,Inc. | -- |
| Trade Name | Q-RejuvalightPro Facewear | dpl® Faceware | LUSTREClearSkinRenew ProFacewearMask | dpl® II Panel | -- |
| ClassificationName | Light BasedOver TheCounterWrinkleReduction(OHS), Over-The-CounterPowered | Light BasedOver TheCounterWrinkleReduction(OHS), Over-The-CounterPowered Light | Light BasedOver TheCounterWrinkleReduction(OHS), Over-The-CounterPowered Light | Light BasedOver TheCounterWrinkleReduction(OHS) | -- |
| Elements ofComparison | SubjectDevice | PredicateDevice 1(Primary) | PredicateDevice 2(Reference) | PredicateDevice 3(Reference) | Remark |
| Light BasedLaser ForAcne (OLP) | Based LaserFor Acne(OLP) | Based LaserFor Acne(OLP) | |||
| 510(k) Number | K230042 | K183247 | K230124 | K171390 | -- |
| Product Code | OHS, OLP | OHS, OLP | OHS, OLP | OLP | Same |
| Intended Use /Indications forUse | The Q-Rejuvalight ProFacewear(Model: P19-0023) is anOver-the-Counter (OTC)deviceintended fortreatment ofwrinkles andmild tomoderateinflammatoryacne. | The dpl®Faceware is anOver-the-Counter (OTC)LED deviceintended foruse in treatingwrinkles andmild tomoderateinflammatoryacne. | The LUSTREClearSkinRenew ProFacewearMask is anover-the-counter deviceintended toemitenergy in thered and blueregion of thelight spectrum,specificallyindicated totreat mild tomoderate acnevulgaris of theface.The LUSTREClearSkinRenew ProFacewearMask is anover-the-counter deviceintended toemitenergy in thered and NearInfra-redspectrum andis intended forthe use in thetreatment offull-facewrinkles. | The dpl® IIPanel is anOver-the-Counter (OTC)deviceintended foruse in treatingwrinkles. | Same |
| Power source | Input: 5V,50/60Hz, 2ALi-ion PolymerBattery: 3.7V,600mAh,2.22Wh | Li-ion Battery5V USB & 3.7V Battery | Lithium battery:3.7V, 1500mAh5.55WhAdapter Input:100-240Va.c.,50/60HzAdapterOutput: 5Vd.c.,1 A | 120-240V ACPower Adapter | SimilarNote 1 |
| Elements ofComparison | SubjectDevice | PredicateDevice 1(Primary) | PredicateDevice 2(Reference) | PredicateDevice 3(Reference) | Remark |
| Wavelengths | 605nm,630nm,660nm,880nm,415nm | 605nm,630nm,660nm,880nm,415nm | Red: 630±5nmBlue: 415±5nmNIF: 830±5nm | 605nm,630nm,660nm, 880nm | Same |
| Power Density | Singlewavelength:605nm:15±5mW/cm²630nm:20±5mW/cm²660nm:25±5mW/cm²880nm:10±5mW/cm²415nm:25±5mW/cm²Total:70mW/cm²(wrinkle)45mW/cm²(acne) | No publiclyavailable | Red: 18mw/cm²NIR: 12mw/cm²Total: 30mw/cm²(wrinkle)Blue: 26mw/cm²Red: 16mw/cm²Total: 42mw/cm² (acne) | Total:70.16mW/cm²(wrinkle) | SimilarNote 2 |
| Irradiancesource | LEDs | LEDs | LEDs | LEDs | Same |
| Total Numberof LEDs | 80pcs | No publiclyavailable | 80pcs | No publiclyavailable | Same |
| LEDDistribution | 630nm+415nm(Double wick):30pcs630nm+605nm(Double wick):25pcs660nm+880nm(Double wick):25pcs | No publiclyavailable | 630nm+415nm(Double wick):30pcs630nm+830nm(Double wick):50pcs | 630nm+830nm(Double wick):50pcs | SimilarNote 4 |
| Treatment area | 81(acne)140(wrinkle) | 81(acne)135.8(wrinkle) | No publiclyavailable | 415cm² | Same |
| Treatment time | 3 minutes pertreatment | 3 minutes pertreatment | 10 minutes | 3 minutes pertreatment | Same |
| Location forUse | Face | Face | Face | Face | Same |
| Environment ofUse | OTC | OTC | OTC | OTC | Same |
| Safety andEMC | IEC 60601-1IEC 60601-1-11IEC 60601-1-2IEC 60601-2-57IEC 62133-2 | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-11IEC 60601-1-2IEC 60601-2-57IEC 62133-2 | IEC 60601-1IEC 60601-1-2 | SimilarNote 3 |
| Elements ofComparison | SubjectDevice | PredicateDevice 1(Primary) | PredicateDevice 2(Reference) | PredicateDevice 3(Reference) | Remark |
| IEC 62471 | IEC 62471 | ||||
| Biocompatibility | ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10ISO 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.
§ 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.