(328 days)
Not Found
No
The device description focuses on LED technology and user-controlled treatment time. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes.
The device is intended for the treatment of full-face wrinkles and fine lines, which indicates a therapeutic purpose.
No
The device is described as an Over-the-Counter (OTC) device intended for the use in treating full-face wrinkles. It emits light to treat wrinkles and fine lines, rather than to diagnose a condition.
No
The device description explicitly states it is a "hand-held light emitting diode (LED) device" and lists hardware components like the handheld unit, power supply, goggles, and travel case. It also mentions functional performance testing and user safety testing, which are typical for hardware devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Nüve for Wrinkles is a light-emitting device that is applied directly to the skin for the treatment of wrinkles. It does not analyze any biological samples.
- Intended Use: The intended use is for treating wrinkles, not for diagnosing or monitoring a condition based on in vitro analysis.
The description clearly indicates it's a therapeutic device that uses light energy applied externally to the body.
N/A
Intended Use / Indications for Use
The Nive for Wrinkles is an Over-the-Counter (OTC) device intended for the use in treating full-face wrinkles.
Product codes
OHS
Device Description
The Nüve for Wrinkles is an over-the-counter hand-held light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and fine lines. The device uses four types of LEDs : 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adiustments required.
The Nuve for Wrinkles system components include the handheld unit containing the LED module , power supply, goggles, and travel case.
The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Entire Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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: Usability Study
Sample Size: 38 participants
Key Results:
100% of the participants were able to demonstrate the light sensitivity test.
100% of the participants were able to use the device successfully.
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines connecting them, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2015
LED Technologies, LLC % Ms. Susan Anthoney-DeWet Aegis Regulatory Incorporated 2424 Dempster Drive Coralville, Iowa 52241
Re: K141181
Trade/Device Name: NUVE FOR WRINKLES 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 2, 2015 Received: March 4, 2015
Dear Ms. Anthoney-DeWet:
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 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 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 (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
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) K141181
Device Name NUVE FOR WRINKLES
Indications for Use (Describe)
The Nive for Wrinkles is an Over-the-Counter (OTC) device intended for the use in treating 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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510(k) Summary
K 141181
This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR § 878.4810. Submission Date: April 1. 2014
- Submitter Information: AEGIS Regulatory, Inc. - Susan Anthoney-DeWet 2424 Dempster Drive Coralville, IA 52241 Tel.: 865-982-5552 Email: sue@fdalistingconsultants.com
For Specifications Developer: LED Technologies
Attn: Ron Ferguson 133 County Road 17 Elizabeth, CO 80107 Tel.: 303-646-0543 x 155 Email: rferguson@ledtechnologies.com
2. General Information
2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction Device 2.2 Common/Usual Name: Red Light Therapy Device 2.3 Proprietary Names: NÜVE for Wrinkles 2.4 Classification: Class II 2.5 Classification Number: 878.4810 2.6 Product Code: OHS 2.7 Regulation Medical Specialty: General & Plastic Surgery 2.8 Review Panel: Office of Device Evaluation (ODE) Division of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1)
3. Device Description:
The Nüve for Wrinkles is an over-the-counter hand-held light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and fine lines. The device uses four types of LEDs : 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adiustments required.
The Nuve for Wrinkles system components include the handheld unit containing the LED module , power supply, goggles, and travel case.
The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).
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4. Indications / Intended Use:
The Nüve for Wrinkles is an Over-the-Counter (OTC) device intended for the use in treating full-face wrinkles.
Rx or OTC:
The Nüve for Wrinkles is an Over the Counter (OTC) device. The labeling, instructions, and User Operations (21 CFR § 801.60 and 61), are designed for layman understanding and use. The predicate devices are OTC.
5. Predicate Devices:
This device is substantially equivalent to the following predicates, which are currently in safe and effective commerce under product code OHS:
-
K120775 - LightStim for Wrinkles (LED Intellectual)
-
K120560- Trinity Wrinkle Remover (Carol Cole Company)
-
K101382-Dpl NUVE (LED Technologies, LLC)
| Device | NUVE for
Wrinkles
LED
Technologies,
LLC
K141181 | LightStim for
Wrinkles
LED Intellectual
K120775 | Trinity Wrinkle
Remover
Carol Cole
Company
K120560 | Dpl NUVE
LED
Technologies
, LLC
K101382 |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | This Submission | A Predicate Device | A Predicate Device | A Predicate
Device |
| Indications | The dpl- Nüve for
Wrinkles is an
Over-the-Counter
(OTC) device
intended for the
use in treating full-
face wrinkles. | The Lightstim for
Wrinkles is an OTC
hand-held device
intended for the
use in the
treatment of full-
face wrinkles | The Trinity Wrinkle
Remover is an
OTC hand-held
device intended for
use in the
treatment of full-
face wrinkles | The Dpl NUVE
is intended to
emit energy in
the red and
infrared region
of the
spectrum for
use in
dermatology
for the
treatment of
periorbital
wrinkles. |
| Anatomical Sites | Entire Face | Entire Face | Entire Face | Periorbital |
| Handheld | Yes | Yes | Yes | Yes |
| Wavelengths | 605,630,660,880n
m | 605,630,660,855n
m | 605,628,642,850n
m | 625, 830nm |
| Modes | On/Off | On/Off | On/Off | On/Off |
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| Irradiance source | LED | LED | LED | LED |
|---|---|---|---|---|
| Visible light LEDs | Yes | Yes | Yes | Yes |
| LED | ||||
| Array/Arrangement | 60 LEDs. Over | |||
| 30cm2 | 72 LEDs. Over | |||
| 40cm2 | 36 LEDs. Over | |||
| 1.25"D | 120 LEDs over | |||
| 30 cm² | ||||
| Energy Level | 65 mW total | 65 mW total | Unknown | 55 mW/cm2 |
| Power Supply | 28v DC power | |||
| supply | 9-volt DC power | |||
| transformer | 4 rechargeable | |||
| batteries | 28v DC power | |||
| supply | ||||
| Treatment Time | 3 minutes daily, 5 | |||
| days per week for | ||||
| 8 weeks | 3 minutes daily, 5 | |||
| days per week for 8 | ||||
| weeks | 3 minutes each | |||
| area, 21 minutes | ||||
| total minimum 5 | ||||
| days per week for 8 | ||||
| weeks | 20 minutes | |||
| every other | ||||
| day, switching | ||||
| heads | ||||
| Target Population | Individuals with | |||
| wrinkles on the | ||||
| face | Individuals with | |||
| wrinkles on the | ||||
| face | Individuals with | |||
| wrinkles on the | ||||
| face | Individuals | |||
| with periorbital | ||||
| lines and | ||||
| wrinkles. | ||||
| Location for Use | OTC | OTC | OTC | OTC |
Summary of the technological characteristics of the device compared to predicate devices:
-
Has the same intended use as the predicate devices (i.e., treatment of full-face wrinkles;
-
Has the similar output (i.e., 65 mW/cm2 ) as the predicate devices;
-
Utilizes the same number of wavelengths (i.e., 4 wavelengths between 605 nm- 880 nm) as the predicate devices:
-
Utilizes the same treatment duration (i.e., 180 seconds) as the predicate devices;
-
Utilizes the same treatment regimen of five days a week for eight weeks.
The NUVE for Wrinkles device and the above referenced predicate devices are Over the Counter Devices used to treat wrinkles as defined in 21 CFR § 878.4810. These devices utilize red and IR diodes between 605nm to 880 nm to provide narrow bands of light energy to treat wrinkles. The performance achieved by these devices is similar with equal power output. The devices are handheld, and intended to be placed directly on the skin. They are manufactured out of similar materials. Based upon comparison to the predicate devices, the NUVE for Wrinkles device has the same intended uses, with similar technological characteristics as the predicate devices. The system performs as intended and does not raise any new safety or effectiveness issues.
6
6. Performance Testing and Standards:
Testing of the Nuve for Wrinkles included functional performance testing, software validation testing and user safety testing.
Safety and functionality testing demonstrates that the Nuve for Wrinkles conforms to various international consensus standards:
IEC 60601-1: (2006): Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance.
IEC 60601-1-2: (2007): Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Compatibility IEC 60825-1: (2007)
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
Safety Of Laser Products - Part 1: Equipment Classification, And Requirements
The Nuve for Wrinkles software was tested and validated in accordance with FDA's "Guidance
for the content of Premarket Submissions for Software Contained in Medical Devices" A Usability Study was conducted with 38 participants.
The results of the study found that:
100% of the participants were able to demonstrate the light sensitivity test.
100% of the participants were able to use the device successfully.
The conclusions drawn from nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices.
7. Statement of Safety and Effectiveness:
The information in this 510(k) submission was used to support the safety and effectiveness of this device with respect to its cited predicates.
8. Substantial Equivalence Discussion
After analysis of safety, indications, intended uses, dose rates, performance, features, design materials, power output, technological properties, treatment areas, treatment regimes and methods of operation, the manufacturer asserts that no significant differences exist between the applicant device and predicates listed in the predicate chart, and no new issues arise for safety and effectiveness. Therefore, substantial equivalency is hereby requested.