(246 days)
Not Found
No
The device description and performance studies focus on LED light therapy and basic software validation, with no mention of AI or ML algorithms.
Yes
Explanation: The device is intended for over-the-counter use to treat mild to moderate inflammatory acne, which is a therapeutic purpose. Additionally, it uses LED light to irradiate the face for a "therapeutic effect" and is compared to a "LED Phototherapy Device."
No
The device is intended for treating mild to moderate inflammatory acne using blue light LEDs and does not perform any diagnostic functions or analyze patient data for diagnostic purposes.
No
The device description clearly outlines hardware components such as LEDs, a handheld design, silicone bristles, an internal battery, and an external adaptor. The performance studies also include testing for electrical safety and other hardware-related standards.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat mild to moderate inflammatory acne" by applying blue light to the face. This is a therapeutic treatment applied directly to the body, not a test performed on a sample taken from the body.
- Device Description: The device uses LEDs to irradiate the face and has a cleaning brush. This aligns with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would involve testing something in vitro (outside of the living body).
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. They typically involve testing samples taken from the body. This device is designed to treat a condition directly on the body.
N/A
Intended Use / Indications for Use
The pmd clean acne is intended for over-the-counter use to treat mild to moderate inflammatory acne.
Product codes (comma separated list FDA assigned to the subject device)
OLP
Device Description
The pmd clean acne adopts light emitting diodes (LED) in the blue (415nm ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect. The pmd clean acne adopts handheld design, LEDs are contained in the blue light treatment window, and on its reverse side, the soft silicone bristols can be used to clean the face before the blue light treatment. The product is provided with internal battery and it can be charged by external adaptor. To prevent irradiation of LED lights to eyes during the treatment, pmd clean acne is equipped with goggles which blocks light energy from LEDs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
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)
Non-clinical testings have been conducted to verify that the pmd clean acne meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:
- A ANSI AAMI ES 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety A and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-1-11, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-57, Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- A IEC 62471, Photobiological safety of lamps and lamp systems
- A IEC 62133-2, Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
The device has been tested for biocompatibility, it complies with the following standards.
- A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23, Biological evaluation of medical devices - Part 23: Tests for irritation
We have also conducted:
- A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
October 27, 2023
Dongguan Hunter Electronic Technology Co., Ltd. % Tracv Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rn 2401 Zhenye International Business Center No. 3101-90, Oianhai Road Shenzhen, Guangdong 518052 China
Re: K230490
Trade/Device Name: PMD Clean Acne. Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA. 4004-PSTO-NA. 4004-LPUR-NA. 4004-CABLUE-NA-INT. 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT 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: February 23, 2023 Received: February 23, 2023
Dear Tracy Che:
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 (the 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 available 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.
1
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Tanisha L. Tanisha L. Hithe
Tanisha L. -s
Canisha L. -s Hithe -S 2023.10.27
00:05:32 -0 00:05:32 -04'00' Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K230490
Device Name
pmd clean acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
Indications for Use (Describe)
The pmd clean acne is intended for over-the-counter use to treat 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510 (k) Summary K230490
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information:
| 510(k) owner's name: | Dongguan Hunter Electronic Technology Co., Ltd. |
|---|---|
| Address: | Room 301, Building 6, 74 Qiaodong Road, Tangxia Town, Dongguan |
| City, Guangdong, P.R. China | |
| Contact person: | Hunter Ye |
| Phone number: | 13554760590 |
| Email: | 13554760590@139.com |
| Date of summary prepared: | 2023-9-22 |
(2) Reason for the submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
| Trade name/model: | pmd clean acne, Model: 4004-CABLUE-NA, 4004-GREY-NA,
4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA,
4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT,
4004-PSTO-INT, 4004-LPUR-INT |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Over-The-Counter Powered Light Based Laser For Acne |
| Regulation number: | 21 CFR 878.4810 |
| Product code: | OLP |
| Review panel: | General & Plastic Surgery |
| Regulation class: | Class II |
(4) Predicate device
| Sponsor | Li-Tek Electronics Technologies |
|---|---|
| Device Name and Model | LED Phototherapy Device. Model:PL-120 |
| 510(k) Number | K162098 |
| Product Code | OLP, OHS |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | II |
(5) Description/ Design of device:
The pmd clean acne adopts light emitting diodes (LED) in the blue (415nm ± 5nm) spectrum to
5
irradiate on the face to realize its therapeutic effect. The pmd clean acne adopts handheld design, LEDs are contained in the blue light treatment window, and on its reverse side, the soft silicone bristols can be used to clean the face before the blue light treatment. The product is provided with internal battery and it can be charged by external adaptor. To prevent irradiation of LED lights to eyes during the treatment, pmd clean acne is equipped with goggles which blocks light energy from LEDs.
(6) Indications for use:
The pmd clean acne is intended for over-the-counter use to treat mild to moderate inflammatory acne.
(7) Materials
| Component
| name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| pmd clean | |||
| acne | Silicone, plastic, glass | Surface-contacting device: Intact skin | Less than 24 hours |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".
| Item | Subject device | Predicate device | Remark |
|---|---|---|---|
| Trade name | pmd clean acne, Model: | ||
| 4004-CABLUE-NA, | |||
| 4004-GREY-NA, | |||
| 4004-YELLOW-NA, | |||
| 4004-PSTO-NA, | |||
| 4004-LPUR-NA, | |||
| 4004-CABLUE-NA-INT, | |||
| 4004-GREY-INT, | |||
| 4004-YELLOW-INT, | |||
| 4004-PSTO-INT, | |||
| 4004-LPUR-INT | LED Phototherapy Device. | ||
| Model:PL-120 | / | ||
| 510 (k) number | Pending | K162098 | / |
| Manufacturer | Dongguan Hunter Electronic | ||
| Technology Co., Ltd. | Li-Tek Electronics | ||
| Technologies | / | ||
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Classification name | Over-The-Counter Powered | ||
| Light Based Laser For Acne | Over-The-Counter | ||
| Powered Light Based Laser | |||
| For Acne | Same |
(8) Technological characteristics and substantial equivalence:
6
| Product code | OLP | OLP, OHS | Same |
|---|---|---|---|
| Class | II | II | Same |
| Indications for use/ | |||
| Intended use | The pmd clean acne is | ||
| intended for over-the- counter | |||
| use to treat mild to moderate | |||
| inflammatory acne. | The red light is intended | ||
| for the treatment of periorbital wrinkles, and | |||
| the blue light is intended | |||
| for the treatment of the | |||
| mild to moderate | |||
| inflammatory acne. | Similar, the | ||
| indications for | |||
| use of the | |||
| subject device | |||
| is within that of | |||
| the predicate | |||
| device. | |||
| Location for use | Face | Face | Same |
| OTC or prescription | OTC | OTC | Same |
| Basic unit characteristics | |||
| Power supply | 3.7V 1000mAh Li-ion Battery | 3.7V 1050mAh Li battery | Similar |
| Weight | 135g | 150g | Different |
| Dimensions | 175.2 * 56 * 37mm | 1876551mm | Different |
| Irradiation area | 11.04cm2±5% | 30cm2±5% | Different |
| Software/ | |||
| Firmware/ | |||
| Microprocessor | |||
| Control? | Yes | Yes | Same |
| Sterilization | Not required | Not required | Same |
| Output specifications | |||
| Light source | Light Emitting Diodes (LED) | Light Emitting Diodes | |
| (LED) | Same | ||
| Wavelength | Blue: 415nm±5nm | Red: 630 ± 3nm, | |
| Blue: 415 ± 3nm | Similar | ||
| Irradiance | Blue: 70mW/cm2±10% | Red: 80mW/cm2±10% | |
| Blue: 65mW/cm2±10% | Similar | ||
| Additional features | |||
| Treatment | |||
| duration | 3 minutes for each part | 3 minutes per target area | Same |
| Materials of | |||
| skin-contacting | |||
| components | Silicone, plastic, glass | ABS plastic | Different |
| Work | |||
| environment | Temperature: 5-30°C | ||
| Humidity: 10-80%RH | |||
| Atmospheric pressure: | |||
| 700hPa-1060hPa | Temperature: 5 ~ 40°C | ||
| Humidity: 10%-80% | |||
| Atmospheric pressure: | |||
| 700hPa-1060hPa | Similar | ||
| Biocompatibility | |||
| feature | All body-contacting | ||
| materials are complied with | |||
| ISO10993-5, ISO 10993-10 | |||
| and ISO 10993-23 | ABS plastic in hand hold | ||
| part can be considered | |||
| safety | Similar | ||
| Electrical safety | IEC 60601-1; | ||
| IEC 60601-1-11; | |||
| IEC 60601-2-57 | IEC 60601-1; | ||
| IEC 60601-1-11; | |||
| IEC 60601-2-57 | Same | ||
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Photobiological | |||
| safety | IEC 62471 | IEC 62471 | Same |
7
Dongguan Hunter Electronic Technology Co., Ltd. 510(k)s - Section 8. 510 (k) Summary
(9) Non-clinical studies and tests performed:
Non-clinical testings have been conducted to verify that the pmd clean acne meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:
- A ANSI AAMI ES 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety A and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-1-11, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
-
IEC 60601-2-57, Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- A IEC 62471, Photobiological safety of lamps and lamp systems
- A IEC 62133-2, Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
The device has been tested for biocompatibility, it complies with the following standards.
- A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
-
ISO 10993-23, Biological evaluation of medical devices - Part 23: Tests for irritation
We have also conducted:
- A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
(10) Conclusion
8
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device pmd clean acne is as safe, as effective, and performs as well as the legally marketed predicate device, K162098, LED Phototherapy Device.