(109 days)
Not Found
No
The description focuses on the LED technology and its physical characteristics, with no mention of AI or ML for treatment control, image analysis, or any other function.
Yes
The device is intended for the "treatment of mild to moderate inflammatory acne" and is described as an "LED device that emits energy to treat mild to moderate acne," indicating a therapeutic purpose.
No
The document states the device is "intended for treatment of mild to moderate inflammatory acne" and "emits energy to treat mild to moderate acne," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is an "over-the-counter light emitting diode (LED) device" and lists physical components such as "Light Beauty Therapy Patches," "USB Cable with an integrated controller," "Mini Dots," "Goggles," and a "Travel pouch." This indicates it is a hardware device with embedded functionality, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of mild to moderate inflammatory acne." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is an LED light therapy device that emits energy to treat acne. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001, PR5001) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Product codes
OLP
Device Description
The LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001 and PR5001 is an over-the-counter light emitting diode (LED) device that emits energy to treat mild to moderate acne. The device uses two types of LEDs: 415 nm and 630nm.
The LUSTRE 3XPRESS Light Beauty Therapy patches components include the device containing two Light Beauty Therapy Patches, an USB Cable with an integrated controller, 120 Mini Dots, a Goggles, a Travel pouch and a User Manual. Among them, mini dots are used for fixed device, goggles are used to protect eyes, and travel pouch are used to store device.
There is a total of 24 LEDs for each model to provide a power intensity of about 30 mw/cm².
The user pastes the device on the treatment area, and the device will shut down automatically after a 3minute after finishing treatment.
The two models are only different in shape. PR6001 is triangular and PR5001 is crescent.
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
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- AAMI/ANSI ES60601-1 2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) — [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- — IEC 60601-1-11 Edition 2.1 2020-07 Medical Electrical Equipment --Part 1: 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 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 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
- — IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems.
- — IEC 62133-2 Edition 1.0 2017-02 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.
- — IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- — IEC 62366-1 Edition 1.1 2020-06 Medical devices - Part 1: Application of usability engineering to medical devices
Biocompatibility: The subject device is biocompatible for its intended use. They are complied with biocompatibility standards ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-23 (Skin Irritation) and ISO 10993-11 (Acute Systemic Toxicity and Material-mediated Pyrogens).
Software verification and validation testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
Cybersecurity: The subject device does not have any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", there's no need for a cybersecurity evaluation.
Usability Testing: Usability testing was conducted on the LUSTRE 3XPRESS Light Beauty Therapy patches (Models: PR6001, PR5001), which complies with IEC 62366-1 and IEC 60601-1-6.
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows 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 is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 3, 2023
Light Tree Ventures Europe B.V. Kim Laurens Manager Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Hague, Netherlands
Re: K230720
Trade/Device Name: LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 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 6, 2023 Received: June 6, 2023
Dear Kim Laurens:
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
1
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,
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, bold font. The text is black and is set against a white background. There is a faint, light blue watermark in the background.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230720
Device Name
LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001, PR5001)
Indications for Use (Describe)
The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001) 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 of K230720
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: June 13, 2023
2. Submitter's Information
Sponsor Name: Light Tree Ventures Europe B.V. Establishment Registration Number: 3017422691 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
Distributor
Distributor Name: Lustre Skin Ltd Address: Alba Innovation Centre, Alba Campus, Livinqston Scotland, UK, EH547GA
Factory
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
Application Correspondent:
Contact Person: Alain Dijkstra Company: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Tel: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com
3. Subject Device Information
Trade Name: LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 Classification Name: Over-The-Counter Powered Light Based Laser For Acne Review Panel: General & Plastic Surgery Product Code: OLP Regulation Number: 21 CFR 878.4810 Regulation Class: II
4. Predicate Device Information
Sponsor: Shenzhen Kaiyan Medical Co Ltd Trade Name: DemarkQ WOW, DemarkQ POP Classification Name: Over-The-Counter Powered Light Based Laser For Acne 510(K) Number: K203214 Review Panel: General & Plastic Surgery Product Code: OLP
4
Regulation Number: 21 CFR 878.4810 Regulation Class: II
5. Device Description
The LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001 and PR5001 is an over-thecounter light emitting diode (LED) device that emits energy to treat mild to moderate acne. The device uses two types of LEDs: 415 nm and 630nm.
The LUSTRE 3XPRESS Light Beauty Therapy patches components include the device containing two Light Beauty Therapy Patches, an USB Cable with an integrated controller, 120 Mini Dots, a Goggles, a Travel pouch and a User Manual. Among them, mini dots are used for fixed device, goggles are used to protect eyes, and travel pouch are used to store device.
There is a total of 24 LEDs for each model to provide a power intensity of about 30 mw/cm².
The user pastes the device on the treatment area, and the device will shut down automatically after a 3minute after finishing treatment.
The two models are only different in shape. PR6001 is triangular and PR5001 is crescent.
6. Intended Use / Indications for Use
The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001, PR5001) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
7. Comparison to predicate device
Compare with the predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between the subject device and predicate devices do not raise new questions of safety or effectiveness.
| Elements of
Comparison | Subject Device | | Predicate Device (Primary
predicated device) | | Remark |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------|
| Company | Light Tree Ventures Europe B.V. | | Shenzhen Kaiyan Medical Co Ltd | | -- |
| Trade Name | LUSTRE 3XPRESS Light Beauty
Therapy patches | | DemarkQ | | -- |
| Model | PR6001 | PR5001 | DemarkQ
WOW (PB
B) | DemarkQ
POP(SJ-72) | -- |
| Classification Name | Over-The-Counter Powered
Light Based Laser For Acne | | Over-The-Counter Powered
Light Based Laser For Acne | | Same |
| 510(k) Number | K230720 | | K203214 | | -- |
| Product Code | OLP | | OLP | | Same |
| Intended Use /
Indications for Use | The LUSTRE 3XPRESS Light
Beauty Therapy patches (Model:
PR6001, PR5001) is an Over-
the-Counter (OTC) device
intended for treatment of mild to
moderate inflammatory acne. | | The DemarkQ is an Over the-
Counter (OTC) device
intended for treatment of mild
to moderate inflammatory
acne. | | Same |
| Power Supply | Input: 100-240Va.c., 50Hz/60Hz, | output: DC 5V, 2A | Power by: 2 x
(3.7Vdc, 2700
mAh Lithium
battery, | Power by:
3.7Vdc,
1500 mAh
lithium | Different
Note 1 |
| | | 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 | | |
| Wavelengths | 630 ± 10nm
415 ± 10nm | 630nm±10nm
415nm±10nm | | Same | |
| Irradiance source | LED | LED | | Same | |
| Number of LEDs | For each model:
Blue: 12
Red: 12
Total :24 | 112 each
panel | Total 72 | Different
Note 2 | |
| Irradiance (mw/cm²) | Red: 5
Blue: 25 | Red: 5
Blue: 25 | Red: 25
Blue: 25±5 | Same | |
| Treatment Time | 3 minutes per treatment | 3 minutes per treatment | | Same | |
| Location for USE | OTC | OTC | | Same | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | | Same | |
| Safety | IEC 60601-1
IEC 60601-2-57
IEC 60601-1-11
IEC 62471 | IEC 60601-1
IEC 60601-2-57
IEC 60601-1-11
IEC 62471 | | Same | |
| Biocompatibility | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-23
ISO 10993-11 | ISO 10993-1,
ISO 10993-5,
ISO 10993-10 | | Similar
Note 3 | |
5
Comparison in Detail(s):
Note 1: Although the "Power Supply" is a little different from the predicate devices, they all complied with the IEC 60601-1 and IEC 60601-1-2 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issues.
Note 2: The "Number of LEDs" is different from the predicate devices, it's because the area of them is different. However, both of them have same "Irradiance". So, these differences will not raise any safety or effectiveness issues.
Note 3: Although the "Biocompatibility" is a little different from the predicate devices, they all meet the
6
requirements of the ISO 10993-1 guidance requirement. So, these slight differences will not raise any safety or effectiveness issues.
8. Test Summary
8.1 Non-Clinical Tests Performed
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- AAMI/ANSI ES60601-1 2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) � [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- � IEC 60601-1-11 Edition 2.1 2020-07 Medical Electrical Equipment --Part 1: 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 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 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
- � IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems.
- � IEC 62133-2 Edition 1.0 2017-02 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.
- � IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- � IEC 62366-1 Edition 1.1 2020-06 Medical devices - Part 1: Application of usability engineering to medical devices
1) Biocompatibility
The subject device is biocompatible for its intended use. They are complied with biocompatibility standards ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-23 (Skin Irritation) and ISO 10993-11 (Acute Systemic Toxicity and Material-mediated Pyrogens).
2) Software verification and validation testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
3) Cybersecurity
The subject device does not have any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", there's no need for a cybersecurity evaluation.
Usability Testing 4)
7
Usability testing was conducted on the LUSTRE 3XPRESS Light Beauty Therapy patches (Models: PR6001, PR5001), which complies with IEC 62366-1 and IEC 60601-1-6.
8.2 Summary of Clinical Performance
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
9. Final Conclusion:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K203214.