(57 days)
K2217752
No
The device description focuses on LED light emission and simple controls (on/off, mode switching, timer). There is no mention of data processing, learning, or adaptive behavior that would indicate AI/ML.
Yes
The device is intended to treat medical conditions (acne vulgaris and wrinkles), which aligns with the definition of a therapeutic device.
No
The device is described as emitting light to treat acne and wrinkles, which are therapeutic functions, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly states it is an "over-the-counter light emitting diode (LED) device" and lists physical components like an LED mask, straps, eye protection, and a USB-C cable, indicating it is a hardware device that utilizes light energy for treatment.
Based on the provided information, the LUSTRE ClearSkin Renew Pro Facewear Mask is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The LUSTRE ClearSkin Renew Pro Facewear Mask is a light-emitting device that applies light energy directly to the skin for therapeutic purposes (treating acne and wrinkles). It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for treating conditions on the face by emitting light energy. There is no mention of analyzing samples or providing diagnostic information.
Therefore, the LUSTRE ClearSkin Renew Pro Facewear Mask falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
Product codes
OHS, OLP
Device Description
LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of acne and wrinkles. The device has anti-wrinkle mode and anti-acne, the former is to emit red light (630nm) and infrared light (830nm) to treat wrinkles, the latter is to emit red light (630nm) and blue light (415nm) to treat mild to moderate acne. There is only one button on the outside of the mask, which have the functions of controlling startup, shutdown, and switching modes. The treatment lasts for 10 minutes by default, and after the treatment, the device will automatically shut down if it is not operated within five minutes. The product contents include an LED mask, Adjustable Velcro Straps, Removable Eye Protection, USB-C cable, cloth bag and user manual, the function of the Removable Eye Protection is to protect the eyes from the harm of led light.
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)
No clinical study is included in this submission.
LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) has been evaluated the safety and performance by lab bench testing.
The device was tested against the following standards:
- ANSI AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- 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 equipment and medical electrical systems used in the home healthcare environment (IEC 60601-11:2015 MOD)
- IEC 60601-1-2 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 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 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
- IEC 62471 Photobiological safety of lamps and lamp systems
The component materials for Adjustable Velcro Straps, Removable Eye Protection, shell (Inner surface), and shell (Outer surface) of the subject device are identical to the corresponding component materials of the K2217752. So, the subject device can comply with the biocompatibility requirements of ISO 10993-5(Cytotoxicity), ISO 10993-10(Sensitization), and ISO 10993-23(Irritation).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K2217752
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.
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March 15, 2023
Light Tree Ventures Europe B.V. Alain Dijkstra CEO Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Hague, Netherlands 2500 Netherlands
Re: K230124
Trade/Device Name: LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) 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: January 12, 2023 Received: January 17, 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.
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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.
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are clear and easy to read, with consistent spacing between the words and characters.
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
2
Indications for Use
510(k) Number (if known) K230124
Device Name
LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)
Indications for Use (Describe)
The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | X |
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510(k) Summary of K230124
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Date of the summary prepared: Feb. 9, 2023 1.
Submitter's Information 2.
Company Name: Light Tree Ventures Europe B.V. Establishment Registration Number: 3017422691 Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Phone: +86-135-10378748 Fax No: 0755-25024651 Contact Person (including title): Alain Dijkstra (Manager) Email: regulation@kaiyanmedical.com
Manufacturer
Company Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Establishment Registration Number: 3011644607 Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Phone: 0755-82129361 Fax No: 0755-25024651 Contact Person (including title): Alain Dijkstra (CEO) Email: alaindijkstra@kaiyanmedical.com
Distributor
Distributor Name: Lusre Skin Ltd Address: Alba Innovation Centre, Alba Campus, Livingston Scotland, UK, Eh547GA
Application Correspondent:
Contact Person: Mr. Alain Dijkstra Company Name: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Haque, The Netherlands Tel: +86 755 82129361 Email: regulation@kaiyanmedical.com
4
Subject Device Information 3.
Type of 510(k): Traditional Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over-The Counter Wrinkle Reduction (OHS) Trade Name: LUSTRE ClearSkin Renew Pro Facewear Mask Model Name: PR4001 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 21 CFR 878.4810 Regulatory Class: II
4. Predicate Device Information
Sponsor: Harpar Grace International Trade Name: Shani Darden LED light therapy mask Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over-The Counter Wrinkle Reduction (OHS) 510(k) Number: K214103 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 21 CFR 878.4810 Regulation Class: II
Device Description 5.
LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of acne and wrinkles. The device has anti-wrinkle mode and anti-acne, the former is to emit red light (630nm) and infrared light (830nm) to treat wrinkles, the latter is to emit red light (630nm) and blue light (415nm) to treat mild to moderate acne. There is only one button on the outside of the mask, which have the functions of controlling startup, shutdown, and switching modes. The treatment lasts for 10 minutes by default, and after the treatment, the device will automatically shut down if it is not operated within five minutes. The product contents include an LED mask, Adjustable Velcro Straps, Removable Eye Protection, USB-C cable, cloth bag and user manual, the function of the Removable Eye Protection is to protect the eyes from the harm of led light.
6. Intended Use / Indications for Use
5
The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face.
The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
7. Comparison to predicate device
Compare with 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 subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Company | LIGHT TREE VENTURES | ||
| EUROPE B.V. | Harpar Grace | ||
| International | -- | ||
| Trade Name | LUSTRE ClearSkin Renew | ||
| Pro Facewear Mask | Shani Darden LED light | ||
| therapy mask | -- | ||
| 510(k) Number | K230124 | K214103 | -- |
| Product Code | OHS, OLP | OHS, OLP | Same |
| Regulation | |||
| Number | 878.4810 | ||
| Laser surgical instrument for | |||
| use in general and | |||
| plastic surgery and in | |||
| dermatology | 878.4810 | ||
| Laser surgical | |||
| instrument for use in | |||
| general and | |||
| plastic surgery and in | |||
| dermatology | Same | ||
| FDA Device | |||
| Classification | Class II | Class II | Same |
| Use | Over the Counter | Over the Counter | Same |
| Intended use | |||
| and | |||
| Indications | The LUSTRE ClearSkin | ||
| Renew Pro Facewear Mask is | |||
| an over-the-counter device | |||
| intended to emit energy in the | |||
| red and blue region of the light | |||
| spectrum, specifically | |||
| indicated to treat mild to | |||
| moderate acne vulgaris of the | The Shani Darden LED | ||
| light therapy mask is an | |||
| over-the-counter device | |||
| intended to emit energy | |||
| in the red and blue | |||
| region of the light | |||
| spectrum, specifically | |||
| indicated to treat mild to | Same | ||
| face. The LUSTRE ClearSkin | |||
| Renew Pro Facewear Mask is | |||
| an over-the-counter device | |||
| intended to emit energy in the | |||
| red and Near Infra-red | |||
| spectrum and is intended for | |||
| the use in the treatment of full- | |||
| face wrinkles. | moderate acne vulgaris | ||
| of the face. The Shani | |||
| Darden LED light | |||
| therapy mask is an | |||
| over-the-counter device | |||
| intended to emit energy | |||
| in the red and Near | |||
| Infra-red spectrum and | |||
| is intended for the use | |||
| in the treatment of full- | |||
| face wrinkles. | |||
| Intended | |||
| Location of Use | Face | Face | Same |
| Energy Type | Light emitting diodes | Light emitting diodes | Same |
| Wavelengths | Red: 630±5nm | ||
| Blue: 415±5nm | |||
| NIF: 830±5nm | Red: 630nm±10nm | ||
| Blue: 415nm±10nm | |||
| NIF: 830nm±10nm | Same | ||
| Intensity | |||
| (mW/cm²) | Blue: 26 mw/cm² | ||
| Red: 16 mw/cm² | |||
| Red: 18 mw/cm² | |||
| NIR: 12 mw/cm² | Blue: 28 mw/cm² | ||
| Red: 16 mw/cm² | |||
| Red: 18 mw/cm² | |||
| NIR: 11 mw/cm² | Similar | ||
| Note 1 | |||
| Total Intensity | |||
| (mW/cm²) | Blue/Red 42 mw/cm² | ||
| Red/NIR 30 mw/cm² | Blue/Red 44 mw/cm² | ||
| Red/NIR 29 mw/cm² | Similar | ||
| Note 1 | |||
| Dose | Blue 15.6J/cm² | ||
| Red 9.6J/cm² | |||
| Red 10.8J/cm² | |||
| NIR 7.2J/cm² | Blue 16.8J/cm² | ||
| Red 9.6J/cm² | |||
| Red 11J/cm² | |||
| NIR 7J/cm² | Similar | ||
| Note 1 | |||
| Total Number | |||
| of LEDs | 80pcs | No publicly available | Different |
| Note 3 | |||
| LED | |||
| Distribution | 630nm+415nm (Double wick): | ||
| 30pcs | |||
| 630nm+830nm (Double wick): | |||
| 50pcs | No publicly available | Different | |
| Note 3 | |||
| Treatment time | 10 minutes | 10 minutes | Same |
| Treatment | Acne: 4 x weekly, 6 weeks | Acne: 4 x weekly, 6 | Same |
| protocol | weeks | ||
| Treatment | |||
| protocol | Wrinkles: 5 x weekly, 6 weeks | Wrinkles: 5 x weekly, 6 weeks | Same |
| Software | |||
| Controlled | Device uses a timer and | ||
| software to control treatment | |||
| duration | Device uses a timer | ||
| and software to control | |||
| treatment duration | Same | ||
| Power supply | Lithium battery: 3.7V, | ||
| 1500mAh 5.55Wh | |||
| Adapter Input: 100-240Va.c., | |||
| 50/60Hz | |||
| Adapter Output: 5Vd.c, 1A | Electrical Input to power | ||
| adaptor: 100v-240v. | |||
| 50/60Hz. Rated at 0.7A. | |||
| Electrical Output from | |||
| power adaptor: 12V, 1A | Different | ||
| Note 2 |
6
7
Comparison in Detail(s):
Note 1: Though the "Intensity (mW/cm²)", "Total Intensity (mW/cm²)" and "Dose" of the subject device are slightly different from the predicate device, the treatment parameters of the subject device are very close to the predicate device and both of them meet the requirements of the IEC 60601-2-57. So, the minor difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
Note 2: The "Power supply" of the subject device is using a Lithium-lon battery and the predicate device is using a power adaptor, both the subject device and the predicate conduct the safety test according to the IEC 60601 series standards, and the test results are 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 3: Although there is no publicly available of the "Total Number of LEDs" and the "LED Distribution" for the predicate device, the subject device has the same / similar treatment parameters in "Intensity", "Total Intensity", "Dose" and "Treatment Time" with the predicate device. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
8. Non-clinical test Summary
8.1 Summary of Electrical safety and EMC
LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) has been evaluated the safety and performance by lab bench testing as following:
8
| Standard
| No. | Standards Title | Version | Date |
|---|---|---|---|
| ANSI AAMI | |||
| ES60601-1 | Medical electrical equipment - Part 1: General | ||
| requirements for basic safety and essential | |||
| performance (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 and | |||
| essential performance -- Collateral Standard: | |||
| Requirements for medical electrical equipment | |||
| and medical electrical equipment and medical | |||
| electrical systems used in the home healthcare | |||
| environment (IEC 60601-1-11:2015 MOD) | Edition 2.1 2020-07 | ||
| CONSOLIDATED | |||
| VERSION | 12/21/2020 | ||
| IEC 60601- | |||
| 1-2 | Medical electrical equipment - Part 1-2: General | ||
| requirements for basic safety and essential | |||
| performance - Collateral Standard: | |||
| Electromagnetic disturbances - Requirements | |||
| and tests | Edition 4.1 2020-09 | ||
| CONSOLIDATED | |||
| VERSION | 12/21/2020 | ||
| 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 | Edition 1.0 2011-01 | 03/16/2012 | |
| 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 | Edition 1.0 2017-02 | 12/23/2019 | |
| IEC 62471 | Photobiological safety of lamps and lamp | ||
| systems | First edition 2006-07 | 08/20/2012 |
8.2 Summary of Biocompatibility
The component materials for Adjustable Velcro Straps, Removable Eye Protection, shell (Inner surface), and shell (Outer surface) of the subject device are identical to the corresponding component materials of the K2217752. So, the subject device can comply with the biocompatibility requirements of ISO 10993-5(Cytotoxicity), ISO 10993-10(Sensitization), and ISO 10993-23(Irritation).
9
9. Clinical test Summary
No clinical study is included in this submission.
Final Conclusion:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K214103.