(262 days)
The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
The DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP(SJ-72) are over-the counter light emitting diode (LED) panel device, that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The devices use two types of LEDs: 630nm red and 415nm blue. The device operated only by one key, both wavelengths will be emitted at the same time when it be turned on. The treatment time is controlled by the user. There are no user settings or adjustments required.
The device's components include the main device which containing the LED treatment module, USB power cord and goggles.
The provided document is a 510(k) summary for the DemarkQ WOW and DemarkQ POP devices, which are LED-based light therapy devices for the treatment of mild to moderate inflammatory acne.
Based on the content, here's an analysis of the acceptance criteria and the "study" that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., efficacy rates, reduction in lesion counts) for the device itself in treating acne. Instead, it focuses on demonstrating Substantial Equivalence (SE) to predicate devices based on technological characteristics and adherence to safety and performance standards.
The "acceptance criteria" can be inferred from the comparison to predicate devices and the listed standards. The implicit acceptance criteria are that the device should:
- Have the same intended use and indications for use as predicate devices.
- Have similar technological characteristics (e.g., wavelengths, type of light source, power supply within safe limits).
- Comply with recognized medical device safety, EMC, usability, and biocompatibility standards.
Inferred Acceptance Criteria and Reported Device Performance (Summary derived from the comparison table):
| Feature/Criteria | Acceptance Criterion (Implicit) | Reported Device Performance (DemarkQ WOW / POP) | Met? |
|---|---|---|---|
| Intended Use | Treatment of mild to moderate inflammatory acne (same as predicates). | "The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne." | Yes |
| Wavelengths | Deliver red and blue light within dermatologist-recognized therapeutic ranges (similar to predicates). | Red: 630nm±10nm, Blue: 415nm±10nm (similar to predicates' 415nm/630nm, 633±10nm/417±10nm) | Yes |
| Irradiance | Deliver light at an irradiance level comparable to predicate devices and within safe therapeutic ranges. | DemarkQ WOW: Red: 5 mW/cm², Blue: 25 mW/cm²; DemarkQ POP: Red: 25 mW/cm², Blue: 25±5 mW/cm² (comparable to predicates, within safety standards). | Yes |
| Light Source | LED-based light source. | LEDs. | Yes |
| Treatment Time | Typical treatment duration (e.g., 3 minutes) per session. | 3 minutes per treatment. Can be used daily. | Yes |
| Power Supply | Safe and effective power delivery, compliant with electrical safety standards. | DemarkQ WOW: Battery (2 x 3.7Vdc, 2700 mAh lithium battery), Adapter Input: 100-240Vac, 50/60Hz, Output: DC 5V, 2A. Main unit input: DC 5V, 2A. DemarkQ POP: Battery (3.7Vdc, 1500 mAh lithium battery), Adapter Input: 100-240Vac, 50/60Hz, Output: DC 5V, 2A. Main unit input: DC 5V, 2A. Compliant with IEC 60601-1, -1-11, -1-2. | Yes |
| EMC | Compliance with electromagnetic compatibility standards. | IEC 60601-1-2. | Yes |
| Electrical Safety | Compliance with general and particular electrical medical equipment safety standards. | IEC 60601-1, IEC 60601-2-57, IEC 60601-1-11, IEC 62471. | Yes |
| Biocompatibility | Compliance with biological evaluation standards for medical devices (for patient contact materials). | ISO 10993-1, ISO 10993-5, ISO 10993-10. | Yes |
| Usability | Compliance with usability standards for medical electrical equipment. | IEC 60601-1-6. | Yes |
| Software | Compliance with medical device software lifecycle standards (if applicable). | IEC 62304. | Yes |
The "study" that proves the device meets the acceptance criteria is primarily a demonstration of Substantial Equivalence (SE) to legally marketed predicate devices through a comparison of technological characteristics and adherence to recognized consensus standards. The document explicitly states: "The DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP(SJ-72) have been evaluated the safety and performance by lab bench testing as following:" followed by a list of international standards.
2. Sample size used for the test set and the data provenance:
The document describes laboratory bench testing and comparison to predicates, not a clinical study on human subjects for efficacy. Therefore, there is no "test set" in the sense of a patient cohort or retrospective dataset for assessing clinical performance. The testing involved samples of the device itself to verify compliance with various safety and performance standards (e.g., electrical safety, EMC, biocompatibility).
- Country of Origin of the data: Based on the submitter's address (Shenzhen, Guangdong, China), the lab bench testing was likely performed in China or by labs accredited to conduct these tests for the Chinese manufacturer.
- Retrospective or Prospective: Not applicable as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. Ground truth, in the context of clinical efficacy, would involve expert assessment of acne lesions or outcomes. Since this 510(k) submission doesn't include a de novo clinical efficacy study, it does not refer to experts establishing ground truth for efficacy. The "experts" involved would be the engineers and testing personnel who evaluated the device against the referenced standards, and possibly the regulatory specialists who prepared the submission, but their qualifications are not detailed here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There is no clinical test set requiring adjudication of findings (e.g., disease presence/absence, lesion counts).
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 an LED light therapy device for acne treatment, not an AI-powered diagnostic or assistive tool for human readers/clinicians, and thus an MRMC study is not relevant or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. Pertains to AI/software performance studies, which is not relevant for this hardware light therapy device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is the compliance with recognized international consensus standards (e.g., IEC, ISO). The device's characteristics (e.g., wavelength, irradiance) were measured against specified parameters outlined in these standards and the comparison to predicate devices, rather than clinical outcomes or expert consensus on clinical images/pathology.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not a machine learning or AI-based device requiring training.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set for an AI/ML model.
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July 22, 2021
Shenzhen Kaiyan Medical Co Ltd Alain Dijkstra CEO 40A Fuxin Road Fuyong Subdistrict BaoAn District Shenzhen, Guangdong 518000 China
Re: K203214
Trade/Device Name: DemarkQ WOW, DemarkQ POP 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: OLP Dated: June 11, 2021 Received: June 15, 2021
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.
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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 (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
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Indications for Use
510(k) Number (if known) K203214
Device Name
DemarkQ, Model: DemarkQ WOW (PB-B), DemarkQ POP (SJ-72)
Indications for Use (Describe)
The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of 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 K203214
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
Company: SHENZHEN KAIYAN MEDICAL CO LTD Establishment Registration Number: 3011644607 Address:40a Fuxin Road Fuyong Subdistrict Baoan District Shenzhen Guangdong, CHINA Phone: 0755-82129361 Fax No: 0755-25024651 Contact Person (including title): Alain Dijkstra(CEO) Email: alaindijkstra@kaiyanmedical.com
Application Correspondent:
Contact Person: Alain Dijkstra SHENZHEN KAIYAN MEDICAL CO LTD Address: 40A Fuxin Road Fuyong Subdistrict BaoAn District Shenzhen, Guangdong, China Tel: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com
2. Subject Device Information
Type of 510(k): Traditional Common Name: WOW LED therapy lamp / POP LED therapy lamp Classification Name: Over-The-Counter Powered Light Based Laser For Acne Trade Name: DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP(SJ-72) Review Panel: General & Plastic Surgery Product Code: OLP Regulation Number: 878.4810 Regulation Class: 2
3. Predicate Device Information
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| Sponsor: | SHENZHEN KAIYAN MEDICAL CO LTD |
|---|---|
| Subject Device: | DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP (SJ-72) |
| Document Name: | FDA 510(k) Submission Report |
| Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | |
|---|---|---|---|
| Sponsor | LED Technologies, Inc. | Medtek Skincare, LLC | Uvbiotek, LLC |
| Device Name and Model | dpl® SpotLite | Poly Clear | LED Light Therapy Device, model:KN-7000C |
| 510(k) Number | K183118 | K183708 | K180900 |
| Product Code | OLP | OLP | OLP |
| Regulation Number | 878.4810 | 878.4810 | 878.4810 |
| Regulation Class | II | II | II |
4. Device Description
The DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP(SJ-72) are over-the counter light emitting diode (LED) panel device, that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The devices use two types of LEDs: 630nm red and 415nm blue. The device operated only by one key, both wavelengths will be emitted at the same time when it be turned on. The treatment time is controlled by the user. There are no user settings or adjustments required.
The device's components include the main device which containing the LED treatment module, USB power cord and goggles.
5. Intended Use / Indications for Use
The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
6. Test Summary
The DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP(SJ-72) have been evaluated the safety and performance by lab bench testing as following:
- IEC 60601-1:2005/(R)2012 and A1:2012. Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-11 Edition 2.0 2015-01, 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 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
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- IEC 60601-2-57 Edition 1.0 2011-01 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 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62304 Edition 1.1 2015-06, Medical device software - Software life cycle processes
- ISO 10993-5 Third edition, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Third Edition, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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7. Comparison to predicate device and conclusion
Compare with predicate device, the subject is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device do not raise and new questions of safety or effectiveness.
| ElementsofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Remark | |
|---|---|---|---|---|---|---|
| Company | SHENZHEN KAIYANMEDICAL CO LTD | LED Technologies,Inc. | Medtek Skincare, LLC | Uvbiotek, LLC | -- | |
| Trade Name | DemarkQ | DemarkQ | dpl SpotLite | Poly Clear | LED Light TherapyDevice | -- |
| Model | DemarkQWOW (PB-B) | DemarkQPOP(SJ-72) | -- | KN-7000C | - | -- |
| ClassificationName | Over-The-Counter PoweredLight Based Laser For Acne | Over-The-CounterPowered LightBased Laser ForAcne | Over-The-CounterPowered Light BasedLaser For Acne | Over-The- CounterLight Based Laser forAcne | SE | |
| 510(k) Number | Applying | K183118 | K183708 | K180900 | -- | |
| Product Code | OLP | OLP | OLP | OLP | SE | |
| Intended Use /Indications forUse | The DemarkQ is an Over-the-Counter (OTC) deviceintended for treatment ofmild to moderateinflammatory acne. | The dpl® SpotLite isan Over-the-Counter(OTC) deviceintended fortreatment of mild tomoderateinflammatory acne. | The Poly Clearcombination of Red(633nm±10nm) andBlue (417nm±10nm) isintended to emitenergy in the red, blueregions of the lightspectrum to treatdermatologicalconditions, specificallyindicated to treat mildto moderate acnevulgaris. | The LED Light TherapyDevice is indicated forthe treatment of mild tomoderate inflammatoryacne | SE | |
| Power Supply | Power by: 2x (3.7Vdc,2700 mAhlithium | Power by:3.7Vdc,1500 mAhlithium | Not publicly available | 100-240V,50/60Hz±2%, 300VA(Mains Connected) | Adaptermodel number:LXCP12-005200DEG,Input: 100-240V a.c.50/60Hz. | SENote 1 |
| battery,10.26Wh)AdapterInput: 100-240Vac,50/60HzAdapterOutput: DC5V, 2AMain unitinput: DC5V, 2A | battery,10.26WhAdapterInput: 100-240Vac,50/60HzAdapterOutput: DC5V, 2AMain unitinput: DC5V, 2A | 0.5Amax. Output: 5Vd.c. 2AMain unit: input: 5V d.c.2A/Internal battery:3.6Vd.c. 2200mAhInternal batteryspecification:CR18650-22F 3.6V d.c.2200mAh | ||||
| Wavelengths | 630nm±10nm415nm±10nm | 415nm, 630nm | 633±10nm417±10nm | Red light 633nm±10nmBlue light 417nm±10nm | SE | |
| Irradiancesource | LEDs | LEDs | No publicly available | LEDs | SE | |
| Number ofLEDs | 112 eachpanel | Total 72 | Not publicly available | Red: 910Blue: 910 | Red: 48Blue: 48Total: 96 | SENote 2 |
| Irradiance(mW/cm²) | Red: 5Blue: 25 | Red: 25Blue: 25±5 | Not publicly available | Combo Red/Bluehead:Red: 30m±10Blue: 20m±10 | Red light 45±5Blue light 25±5 | SENote 2 |
| Timerangeand frequency | 3 minutes per treatment.Can be used daily. | 3 minutes pertreatment | No publicly available | 3 minutes per skinarea. Can be useddaily. | SE | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | SE | |
| Safety | IEC 60601-1IEC 60601-2-57IEC 60601-1-11IEC 62471 | IEC 60601-1 | IEC 60601-1IEC 60601-2-57IEC 62471 | IEC 60601-1IEC 60601-1-11IEC 60601-2-57IEC 62471 | SE | |
| Biocompatibility | ISO 10993-1,ISO 10993-5,ISO 10993-10 | ISO 10993-5,ISO 10993-10 | -- | ISO 10993-1,ISO 10993-5,ISO 10993-10 | SE |
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Sponsor: SHENZHEN KAIYAN MEDICAL CO LTD DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP (SJ-72) Subject Device: FDA 510(k) Submission Report Document Name:
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Sponsor: SHENZHEN KAIYAN MEDICAL CO LTD DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP (SJ-72) Subject Device: FDA 510(k) Submission Report Document Name:
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Comparison in Detail(s):
Note 1:
Although the "Power Supply" is different from the predicate devices, but they all complied with the IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issue.
Note 2:
Although the "Number of LEDs" and "Irradiances" are different from the predicate devices, But they are all within the scope of comparing device parameters and they all complied with the IEC 60601-1, IEC 60601-1-2, IEC 62471 and IEC 60601-2-57 safety standards' requirements. So, these differences will not raise any safety or effectiveness issue.
Final Conclusion:
After an analysis of the safety indications, intended uses, performance, and other technological characteristics, the Sponsor believes that no significant differences exist between the new device and the predicate devices and no new issues of safety or effectiveness are raised. Thus, the subject device DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP(SJ-72) are Substantial Equivalence to the predicate devices K183118, K183708 and K180900.
- Date of the summary prepared: June 11, 2021
§ 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.