(262 days)
Not Found
No
The device description is for a simple LED panel with fixed wavelengths and no user settings, and there are no mentions of AI, ML, image processing, or data sets for training/testing.
Yes
The device is intended for the "treatment of mild to moderate inflammatory acne," which directly relates to its therapeutic purpose.
No
The device is described as being "intended for treatment of mild to moderate inflammatory acne," which indicates a therapeutic purpose rather than a diagnostic one.
No
The device description explicitly states it is an "over-the counter light emitting diode (LED) panel device" and lists physical components like the "main device which containing the LED treatment module, USB power cord and goggles." This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the DemarkQ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "treatment of mild to moderate inflammatory acne." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is an LED panel that emits light for treatment. It does not involve testing samples of human origin (like blood, urine, or tissue) outside of the body, which is the core characteristic of an IVD.
- Performance Studies: The performance studies listed are related to electrical safety, usability, software, and biological evaluation (cytotoxicity and irritation), which are typical for therapeutic devices, not IVDs. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).
IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The DemarkQ device directly applies light to the skin for treatment.
N/A
Intended Use / Indications for Use
The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Product codes (comma separated list FDA assigned to the subject device)
OLP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below it. The logo is clean and professional, reflecting the organization's role in regulating food and drugs.
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.
1
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
2
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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3
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
4
| 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.
5
- 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
6
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.
| Elements
of
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Remark | |
|---|---|---|---|---|---|---|
| Company | SHENZHEN KAIYAN | |||||
| MEDICAL CO LTD | LED Technologies, | |||||
| Inc. | Medtek Skincare, LLC | Uvbiotek, LLC | -- | |||
| Trade Name | DemarkQ | DemarkQ | dpl SpotLite | Poly Clear | LED Light Therapy | |
| Device | -- | |||||
| Model | DemarkQ | |||||
| WOW (PB- | ||||||
| B) | DemarkQ | |||||
| POP(SJ-72) | -- | KN-7000C | - | -- | ||
| Classification | ||||||
| Name | Over-The-Counter Powered | |||||
| Light Based Laser For Acne | Over-The-Counter | |||||
| Powered Light | ||||||
| Based Laser For | ||||||
| Acne | Over-The-Counter | |||||
| Powered Light Based | ||||||
| Laser For Acne | Over-The- Counter | |||||
| Light Based Laser for | ||||||
| Acne | SE | |||||
| 510(k) Number | Applying | K183118 | K183708 | K180900 | -- | |
| Product Code | OLP | OLP | OLP | OLP | SE | |
| Intended Use / | ||||||
| Indications for | ||||||
| Use | The DemarkQ is an Over- | |||||
| the-Counter (OTC) device | ||||||
| intended for treatment of | ||||||
| mild to moderate | ||||||
| inflammatory acne. | The dpl® SpotLite is | |||||
| an Over-the-Counter | ||||||
| (OTC) device | ||||||
| intended for | ||||||
| treatment of mild to | ||||||
| moderate | ||||||
| inflammatory acne. | The Poly Clear | |||||
| combination of Red | ||||||
| (633nm±10nm) and | ||||||
| Blue (417nm±10nm) is | ||||||
| intended to emit | ||||||
| energy in the red, blue | ||||||
| regions of the light | ||||||
| spectrum to treat | ||||||
| dermatological | ||||||
| conditions, specifically | ||||||
| indicated to treat mild | ||||||
| to moderate acne | ||||||
| vulgaris. | The LED Light Therapy | |||||
| Device is indicated for | ||||||
| the treatment of mild to | ||||||
| moderate inflammatory | ||||||
| acne | SE | |||||
| Power Supply | Power by: 2 | |||||
| x (3.7Vdc, | ||||||
| 2700 mAh | ||||||
| lithium | Power by: | |||||
| 3.7Vdc, | ||||||
| 1500 mAh | ||||||
| lithium | Not publicly available | 100-240V, | ||||
| 50/60Hz±2%, 300VA | ||||||
| (Mains Connected) | Adaptermodel number: | |||||
| LXCP12-005200DEG, | ||||||
| Input: 100-240V a.c. | ||||||
| 50/60Hz. | SE | |||||
| Note 1 | ||||||
| battery, | ||||||
| 10.26Wh) | ||||||
| Adapter | ||||||
| Input: 100- | ||||||
| 240Vac, | ||||||
| 50/60Hz | ||||||
| Adapter | ||||||
| Output: DC | ||||||
| 5V, 2A | ||||||
| Main unit | ||||||
| input: DC | ||||||
| 5V, 2A | battery, | |||||
| 10.26Wh | ||||||
| Adapter | ||||||
| Input: 100- | ||||||
| 240Vac, | ||||||
| 50/60Hz | ||||||
| Adapter | ||||||
| Output: DC | ||||||
| 5V, 2A | ||||||
| Main unit | ||||||
| input: DC | ||||||
| 5V, 2A | 0.5Amax. Output: 5V | |||||
| d.c. 2A | ||||||
| Main unit: input: 5V d.c. | ||||||
| 2A/Internal battery: | ||||||
| 3.6Vd.c. 2200mAh | ||||||
| Internal battery | ||||||
| specification: | ||||||
| CR18650-22F 3.6V d.c. | ||||||
| 2200mAh | ||||||
| Wavelengths | 630nm±10nm | |||||
| 415nm±10nm | 415nm, 630nm | 633±10nm | ||||
| 417±10nm | Red light 633nm±10nm | |||||
| Blue light 417nm±10nm | SE | |||||
| Irradiance | ||||||
| source | LEDs | LEDs | No publicly available | LEDs | SE | |
| Number of | ||||||
| LEDs | 112 each | |||||
| panel | Total 72 | Not publicly available | Red: 910 | |||
| Blue: 910 | Red: 48 | |||||
| Blue: 48 | ||||||
| Total: 96 | SE | |||||
| Note 2 | ||||||
| Irradiance | ||||||
| (mW/cm²) | Red: 5 | |||||
| Blue: 25 | Red: 25 | |||||
| Blue: 25±5 | Not publicly available | Combo Red/Blue | ||||
| head: | ||||||
| Red: 30m±10 | ||||||
| Blue: 20m±10 | Red light 45±5 | |||||
| Blue light 25±5 | SE | |||||
| Note 2 | ||||||
| Time | ||||||
| range | ||||||
| and frequency | 3 minutes per treatment. | |||||
| Can be used daily. | 3 minutes per | |||||
| treatment | No publicly available | 3 minutes per skin | ||||
| area. Can be used | ||||||
| daily. | SE | |||||
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | SE | |
| Safety | IEC 60601-1 | |||||
| IEC 60601-2-57 | ||||||
| IEC 60601-1-11 | ||||||
| IEC 62471 | IEC 60601-1 | IEC 60601-1 | ||||
| IEC 60601-2-57 | ||||||
| IEC 62471 | IEC 60601-1 | |||||
| IEC 60601-1-11 | ||||||
| IEC 60601-2-57 | ||||||
| IEC 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 |
7
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:
8
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:
9
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