(78 days)
The Neutrogena Light Therapy Aging Mask+ is an over the counter device that is indicated for the treatment of full face wrinkles.
The Neutrogena Light Therapy Aging Mask+ uses known LED light therapy technology for the treatment of facial wrinkles. The device emits a combination of red light and infrared light. Users place the lightweight mask over the face and press the "On" button on the controller module to start treatment. The device will automatically turn off after each 10-minute treatment.
The provided document focuses on the FDA's 510(k) clearance for the Neutrogena Light Therapy Aging Mask+ and primarily uses substantial equivalence to predicate devices, rather than establishing new acceptance criteria and proving the device meets them through clinical studies with specific performance metrics.
Therefore, the information required to answer your questions regarding acceptance criteria, study details, expert involvement, and ground truth establishment (as typically found in clinical trials for new efficacy claims) is not present in this document.
The document states: "Performance testing performed on the Neutrogena Light Therapy Aging Mask+ is sufficient to demonstrate that the subject device is as safe and effective as the legally marketed predicate devices." This indicates that the primary method for demonstrating effectiveness was through comparison to existing devices with established safety and efficacy profiles, rather than establishing new, quantitative performance criteria for wrinkle reduction itself.
However, I can extract the following information that is available:
1. Table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria for wrinkle reduction performance or report the device's performance against such criteria. Instead, it compares the technological characteristics and indications for use of the subject device to predicate devices to demonstrate substantial equivalence.
| Device Feature | Neutrogena Light Therapy Aging Mask+ (Subject Device) |
|---|---|
| Intended Use | Light-based treatment to reduce wrinkles on the body in general or specific anatomical area |
| Indications for Use | The Neutrogena Light Therapy Aging Mask+ is an over the counter device that is indicated for the treatment of full face wrinkles. |
| Wavelength (nm) | Red 620-640nm, IR 820-880nm |
| Intensity (mW/cm²) | 1.32 mW/cm² |
| Treatment Regimen | 10 minutes/day for 60 sessions |
| Total Energy Dose (J/cm²) | 47.58 J/cm² |
2. Sample size used for the test set and the data provenance: Not provided in the document for efficacy testing. The performance and safety testing mentioned are:
* Performance verification
* Human Factors Evaluation
* Biocompatibility testing
* Electrical Safety and Electromagnetic Compatibility testing
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. This type of information would typically be relevant for studies involving qualitative assessments (e.g., by dermatologists for wrinkle severity), which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a light therapy device, not an algorithm.
7. The type of ground truth used: Not explicitly stated for performance/efficacy, as the primary basis for clearance is substantial equivalence. For safety assessments, recognized standards (biocompatibility, electrical safety) serve as the "ground truth" or reference.
8. The sample size for the training set: Not applicable, as this refers to a medical device's clearance based on technological characteristics and comparison to predicates, not an AI model's training.
9. How the ground truth for the training set was established: Not applicable.
In summary, the FDA 510(k) clearance process for this device relies heavily on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than presenting a novel clinical study with new, specific performance acceptance criteria for wrinkle reduction. The provided document details the technological characteristics and safety testing (bench, human factors, biocompatibility, electrical safety) that support this substantial equivalence claim.
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June 19, 2018
Johnson & Johnson Consumer, Inc. Cindy Abraham Associate Director, Regulatory Affairs 7050 Camp Hill Road Fort Washington, Pennsylvania 19034
Re: K180856
Trade/Device Name: Neutrogena Light Therapy Aging Mask+ 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 Dated: March 21, 2018 Received: April 2, 2018
Dear Cindy Abraham:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 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); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180856
Device Name
Neutrogena Light Therapy Aging Mask+
Indications for Use (Describe)
The Neutrogena Light Therapy Aging Mask+ is an over the counter device that is indicated for the treatment of full face wrinkles.
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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ട്. 510(k) SUMMARY
| 510(k) NUMBER: | K180856 |
|---|---|
| 510(k) SUBMITTER: | Johnson & Johnson Consumer, Inc.7050 Camp Hill RoadFort Washington, PA 19034 |
| CONTACT: | Cindy R. AbrahamAssociate Director, Regulatory Affairscabraha3@its.jnj.com |
| DATE PREPARED: | March 21, 2018 |
| PROPRIETARY NAME: | Neutrogena® Light Therapy Aging Mask+ |
| PANEL: | General & Plastic Surgery |
| REGULATION NUMBER: | CFR Title 21, 878.4810 |
| CLASSIFICATION: | Class II |
| PRODUCT CODES: | OHS |
| COMMON NAME: | Light-based Over The Counter Wrinkle Reduction |
Predicate Devices [807.92(a)(3)] 5.1
5.2 Device Description [807.92(a)(4)]
The Neutrogena Light Therapy Aging Mask+ uses known LED light therapy technology for the treatment of facial wrinkles. The device emits a combination of red light and infrared light. Users place the lightweight mask over the face and press the "On" button on the controller module to start treatment. The device will automatically turn off after each 10-minute treatment.
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Intended Use and Indications for Use [807.92(a)(5)] 5.3
The Neutrogena Light Therapy Aging Mask+ is an over the counter device that is indicated for the treatment of full face wrinkles.
5.4 Comparison of Technological Characteristics with the Predicate Devices [807.92(a)(6)]
The Neutrogena Light Therapy Aging Mask+ is substantially equivalent to the predicate devices in that it has the same intended use and technological characteristics, as demonstrated in Table 5.1. Performance testing performed on the Neutrogena Light Therapy Aging Mask+ is sufficient to demonstrate that the subject device is as safe and effective as the legally marketed predicate devices. The technological and labeling differences do not raise new or different questions about safety or effectiveness. The Neutrogena Light Therapy Aging Mask+ is substantially equivalent to the predicate devices.
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| Device Feature | Johnson & JohnsonNeutrogena LightTherapy AgingMask+Subject Device | LG ElectronicsLG Beauty LEDMaskPredicate 1 | TrophyRejuvalite MDPredicate 2 | La Lumiere, LLCPro X OTC 5 LightTherapyPredicate 3 |
|---|---|---|---|---|
| 510(k) Number | Not yet assigned | K170984 | K133896 | K140471 |
| Classification | 21 CFR 878.4810 | |||
| Common Name | Light-based over-the-counter wrinkle reduction | |||
| Intended Use | Light-based treatment to reduce wrinkles on the body in general or specific anatomical area | |||
| Product Code | OHS | |||
| Rx and/or OTC | OTC | |||
| Use Environment | Home-Use | |||
| AnatomicalLocation | Full face | |||
| Indications forUse | The NeutrogenaLight Therapy AgingMask+ is an over thecounter device that isindicated for thetreatment of full facewrinkles. | The LG BEAUTYLED MASK is anover the counterdevice that isintended for the usein the treatment offull face wrinkles. | The Rejuvalite MD isan Over the Counterdevice that isintended for the usein the treatment offull face wrinkles. | The Pro X OTC 5 isan Over-The-Counterdevice intended foruse in the treatmentof facial wrinkles. Itis for people withwrinkles on their faceand who haveFitzpatrick skin typesI, II and/or III. |
| Power Source | Nickel-MetalHydride rechargeablebatteries | Li-Ion rechargeablebatteries | AC to DC | AA alkaline batteries |
| Energy Source | Light-emitting diodes | |||
| Wavelength (nm) | Red 620-640nmIR 820-880nm | Red 637nmIR 854nm | Red 600, 622, 660nmIR 860nm | Red 620-640nmIR 820-880nm |
| Intensity(mW/cm²) | 1.32 mW/cm² | 4.08 mW/cm² | 2.35 mW/cm² | 0.76 mW/cm² |
| TreatmentRegimen | 10 minutes/day for 60sessions | 9 minutes/day, 5days a week for 8weeks | 3 minutes/day, 5 daysa week for 8 weeks | 15 minutes/day for 60sessions |
| Total EnergyDose (J/cm²) | 47.58 J/cm² | 88.21 J/cm² | 16.94 J/cm² | 41.23 J/cm² |
Table 5.1 Technological Characteristics
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ર.5 Performance Data [807.92(b)(1), (b)(2)]
Performance bench and safety testing include
- . Performance verification
- Human Factors Evaluation .
- Biocompatibility testing in accordance with requirements put forth in . ISO 10993-1
- Electrical Safety and Electromagnetic Compatibility testing .
The verification, electrical safety testing, electromagnetic compatibility testing, and human factors data presented in this 510(k) submission demonstrate the Neutrogena Light Therapy Aging Mask+ device met the established specifications for its intended use and environment of use In addition, the testing demonstrated that the subject device does not raise new or different questions of safety or effectiveness when compared to the legally-marketed predicate devices.
5.6 Conclusion [807.92(b)(3)]
The basis for substantial equivalence for the Neutrogena Light Therapy Aging Mask+ device and the predicate devices is performance data and conformity with recognized standards. Performance bench verification and validation demonstrate that the subject device performs comparably to the predicate devices that are marketed for the same intended use. Based on the performance testing and the similarities of the indications for use and the technological characteristics, it can be concluded that the Neutrogena Light Therapy Aging Mask+ device is substantially equivalent to the predicate devices.
§ 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.