(78 days)
Not Found
No
The description focuses on LED light therapy and automatic shut-off, with no mention of AI or ML capabilities.
Yes
The device is indicated for the "treatment of full face wrinkles," which is a therapeutic purpose.
No
The device is indicated for the "treatment of full face wrinkles" and uses LED light therapy for this purpose. It does not perform any diagnostic function to detect, monitor, or identify a condition.
No
The device description explicitly mentions a physical mask, a controller module with an "On" button, and LED light therapy technology, all of which are hardware components. The performance studies also include hardware-related testing like electrical safety and biocompatibility.
Based on the provided information, the Neutrogena Light Therapy Aging Mask+ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. This typically involves things like blood, urine, tissue, etc., to diagnose diseases or conditions.
- The Neutrogena Light Therapy Aging Mask+ is a device that applies light directly to the skin. Its intended use is for the treatment of wrinkles on the face, which is a direct application of therapy to the body, not the analysis of a specimen taken from the body.
The description clearly indicates it's a light therapy device for topical treatment, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / 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.
Product codes
OHS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Full face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home-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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 Road | |
| Fort Washington, PA 19034 | |
| CONTACT: | Cindy R. Abraham |
| Associate Director, Regulatory Affairs | |
| cabraha3@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.
4
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 & Johnson
Neutrogena Light
Therapy Aging
Mask+
Subject Device | LG Electronics
LG Beauty LED
Mask
Predicate 1 | Trophy
Rejuvalite MD
Predicate 2 | La Lumiere, LLC
Pro X OTC 5 Light
Therapy
Predicate 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 | | | |
| Anatomical
Location | Full face | | | |
| 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. | The LG BEAUTY
LED MASK is an
over the counter
device that is
intended for the use
in the treatment of
full face wrinkles. | The Rejuvalite MD is
an Over the Counter
device that is
intended for the use
in the treatment of
full face wrinkles. | The Pro X OTC 5 is
an Over-The-Counter
device intended for
use in the treatment
of facial wrinkles. It
is for people with
wrinkles on their face
and who have
Fitzpatrick skin types
I, II and/or III. |
| Power Source | Nickel-Metal
Hydride rechargeable
batteries | Li-Ion rechargeable
batteries | AC to DC | AA alkaline batteries |
| Energy Source | Light-emitting diodes | | | |
| Wavelength (nm) | Red 620-640nm
IR 820-880nm | Red 637nm
IR 854nm | Red 600, 622, 660nm
IR 860nm | Red 620-640nm
IR 820-880nm |
| Intensity
(mW/cm²) | 1.32 mW/cm² | 4.08 mW/cm² | 2.35 mW/cm² | 0.76 mW/cm² |
| Treatment
Regimen | 10 minutes/day for 60
sessions | 9 minutes/day, 5
days a week for 8
weeks | 3 minutes/day, 5 days
a week for 8 weeks | 15 minutes/day for 60
sessions |
| Total Energy
Dose (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.