(93 days)
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fines and wrinkles and increase in circulation within the perioral region.
The LED Lip Perfector (Model: ZC-05) is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat fine lines and increase circulation within the perioral region. The device contains four types of LEDs: 605nm, 630nm, and 850nm The LED Lip Perfector components include the main device, charging base, power cord, alternative mouthpiece, user manual, and storage bag. There is only one button on the top edge of the main unit. Short press the power button to turn on the device, and long press the power button to turn off the device. This device only has one treatment mode. The LED Lip Perfector is applied to the skin to ensure consistent light administration during each treatment. The device is sold Over the Counter (OTC).
The provided text is a 510(k) summary for the LED Lip Perfector (Model: ZC-05). It focuses on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to recognized standards. It does not contain information about acceptance criteria or a study proving device performance in the context of clinical effectiveness or statistical superiority/non-inferiority.
Specifically, the document states: "The LED Lip Perfector (Model: ZC-05) has been evaluated the safety and performance by lab bench testing as following:" and then lists a series of recognized standards (e.g., IEC 60601-1, ISO 10993) related to electrical safety, electromagnetic compatibility, usability, and biocompatibility.
The conclusion is based on comparing the subject device to the predicate device in terms of design, intended use, indications for use, functions, materials, and applicable standards, as well as adherence to these safety and performance standards. It explicitly states: "The subject device is as safe, as effective, and performs as well as the legally marketed predicated devices K172662." This implies that by meeting the same safety and performance benchmarks as the predicate, and having similar characteristics and indications for use, it is considered "effective" in the regulatory sense for substantial equivalence, rather than through a dedicated clinical performance study with specific acceptance criteria.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance or details about a study proving the device meets effectiveness criteria, as this information is not present in the provided text. The document is primarily a regulatory submission demonstrating substantial equivalence through technical and safety standards, not a clinical performance study report.
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March 9, 2023
Light Tree Ventures Europe B.V. Alain Dijkstra Manager Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Hague, Netherlands
Re: K223642
Trade/Device Name: LED Lip Perfector, model: ZC-05 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. ILY Dated: February 15, 2023 Received: February 15, 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.
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
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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, clear font. The text is horizontally oriented and appears to be a title or heading. The font is simple and sans-serif, making it easy to read. The background is plain, which helps the text stand out.
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
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Indications for Use
510(k) Number (if known) K223642
Device Name LED Lip Perfector (Model: ZC-05)
Indications for Use (Describe)
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fines and wrinkles and increase in circulation within the perioral region.
| 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 of K223642
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: March 3, 2023 1.
Submitter's Information 2.
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:
Company: CurrentBody.com Ltd Add: Unit D6, Stanley Green Business Park, Commercial Avenue, Cheadle Hulme,Cheshire, SK8 6QH
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: LED Lip Perfector, model: ZC-05 Trademark: CurrentBody Skin™ Classification Name: Light Based Over-The-Counter Wrinkle Reduction Review Panel: General & Plastic Surgery Product Code: OHS, ILY Regulation Number: 21 CFR 878.4810 Regulation Class: II
4. Predicate Device Information
Sponsor: LED Technologies, Inc. Trade Name: reVive Perioral LED Light Therapy System Classification Name: Light Based Over-The-Counter Wrinkle Reduction device 510(K) Number: K172662 Review Panel: General & Plastic Surgery Product Code: OHS, ILY Regulation Number: 21 CFR 878.4810 Regulation Class: II
5. Device Description
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The LED Lip Perfector (Model: ZC-05) is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat fine lines and increase circulation within the perioral region. The device contains four types of LEDs: 605nm, 630nm, and 850nm The LED Lip Perfector components include the main device, charging base, power cord, alternative mouthpiece, user manual, and storage bag. There is only one button on the top edge of the main unit. Short press the power button to turn on the device, and long press the power button to turn off the device.
This device only has one treatment mode. The LED Lip Perfector is applied to the skin to ensure consistent light administration during each treatment. The device is sold Over the Counter (OTC).
Intended Use / Indications for Use 6.
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fine lines and wrinkles and increase in circulation within the perioral region.
Comparison to predicate device 7.
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 ofComparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Company | Light Tree Ventures EuropeB.V. | LED Technologies, Inc. | -- |
| Trade Name | LED Lip Perfector | reVive Perioral LED LightTherapy System | -- |
| Model | ZC-05 | / | -- |
| Classification Name | Light Based Over-The-Counter Wrinkle Reduction | Light Based Over-The-Counter Wrinkle Reductiondevice | -- |
| 510(k) Number | Applying | K172662 | -- |
| Product Code | OHS, ILY | OHS, ILY | Same |
| Intended Use /Indications for Use | The LED Lip Perfector(Model: ZC-05) is an Over-the-Counter (OTC) deviceintended to treat fine linesand wrinkles and increase incirculation within the perioralregion. | The reVive® Perioral LEDLight Therapy system is anOver-the-Counter (OTC)device intended for thetreatment fine lines andwrinkles, and increase incirculation within the perioralregion. | Same |
| Design | Hand-held device | Hand-held device | Same |
| Type of use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Treatment Distance | Applied directly to the skin | Applied directly to the skin | Same |
| Treatment Sites | Perioral region | Perioral region | Same |
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| Change in energy (theaddition of battery) | Yes | Yes | Same |
|---|---|---|---|
| Power Supply | 3.7V lithium battery | 3.7V lithium battery | Same |
| Treatment Range | 3 minutes per treatment | 3 minutes per treatment | Same |
| Wavelengths | 605nm, 630nm, 660nm,850nm | 605nm, 630nm, 660nm,880nm | Different,Note |
| Location for USE | OTC | OTC | Same |
| Number of LEDs | Total 56 LEDs605nm: 14660nm: 14630nm: 14880nm: 14 | Total 56 LEDs605nm: 14660nm: 14630nm: 14880nm: 14 | Same |
| Energy Level | 67.7±10% mW/cm $2$ | 67.7 mW/cm $2$ | Same |
| Treatment Area | 24 cm $2$ | 24 cm $2$ | Different |
| Irradiance source | LED | LED | Same |
| Visible light LEDs | Yes | Yes | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | Same |
Note:
Although the "Wavelengths" of subject device is a little different from the predicate device, they are both have a same intended use and the "Energy Level" is the same. So, the differences between the subject device and predicate device will not raise any safety or effectiveness issue.
8. Test Summary
The LED Lip Perfector (Model: ZC-05) has been evaluated the safety and performance by lab bench testing as following:
| StandardsNo. | Standard Title | Version | Date | RecognitionNumber | Location |
|---|---|---|---|---|---|
| IEC 60601-1 | Medical electricalequipment - Part 1:General requirements forbasic safety and essentialperformance | 2005/AMD1:2012,IEC 60601-1:2005/AMD2:2020 | / | / | Attachment9 |
| IEC 60601-1-11 | Medical electricalequipment - Part 1-11:General requirements forbasic safety and essentialperformance - CollateralStandard: Requirements formedical electricalequipment and medicalelectrical systems used inthe home healthcareenvironment | Edition 2.1 2020-07 | 12/21/2020 | 19-38 | Attachment9 |
| IEC 60601-2-57 | Medical ElectricalEquipment - Part 2-57:Particular requirements forthe basic safety andessential performance ofnon-laser light sourceequipment intended fortherapeutic, diagnostic,monitoring andcosmetic/aesthetic use | Edition 1.0 2011-01 | 03/16/2012 | 12-242 | Attachment9 |
| IEC 60601-1-2 | Medical ElectricalEquipment - Part 1-2:General Requirements ForBasic Safety And EssentialPerformance - CollateralStandard: ElectromagneticDisturbances --Requirements And Tests | 60601-1-2 Edition4.1 2020-09 | 12/21/2020 | 19-36 | Attachment9 |
| IEC 60601-1-6 | Medical electricalequipment - Part 1-6:General requirements forbasic safety and essentialperformance - Collateralstandard: Usability | Edition 3.2 2020-07 | 12/21/2020 | 5-132 | Attachment9 |
| IEC 62133-2 | Secondary cells andbatteries containingalkaline or other non-acidelectrolytes - Safetyrequirements for portablesealed secondary cells,and for batteries made fromthem, for use in portableapplications - Part 2:Lithium systems | Edition 1.0 2017-02 | 12/23/2019 | 19-33 | Attachment9 |
| ISO 10993-5 | Biological evaluation ofmedical devices - Part 5:Tests for in vitro cytotoxicity | Third edition | 2009-06-01 | 2-245 | / |
| ISO 10993-10 | Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization | Third Edition | 2010-08-01 | 2-174 | / |
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9. Final Conclusion
The subject device is as safe, as effective, and performs as well as the legally marketed predicated devices K172662.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.