(160 days)
Not Found
No
The device description and summary of performance studies focus on electrical stimulation and compliance with safety standards, with no mention of AI or ML.
No
The "Intended Use / Indications for Use" section explicitly states it is for "over-the-counter cosmetic use" and the "Device Description" states it is "Not for use in any therapy or for the treatment, diagnosis, prevention or cure of any medical conditions or diseases."
No
The "Intended Use" states it is for "facial stimulation" and "over-the-counter cosmetic use". The "Device Description" explicitly states, "Not for use on injured or otherwise impaired skin or muscles, or use in any therapy or for the treatment, diagnosis, prevention or cure of any medical conditions or diseases."
No
The device description explicitly states it is a "battery-powered portable EMS device" that "applied specially designed bi-polar low voltage micro-current impulses," indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, the Ageless Wonder Facial Toning Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "facial stimulation" for "over-the-counter cosmetic use." This is a cosmetic purpose, not a diagnostic one.
- Device Description: The description focuses on applying electrical impulses to the face for muscle stimulation. It explicitly states it is "Not for use... for the treatment, diagnosis, prevention or cure of any medical conditions or diseases."
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (like blood, urine, or tissue) or providing any diagnostic information about a person's health or condition. IVDs are designed to perform tests on these types of samples to aid in diagnosis.
- Standards: While the device conforms to several medical device standards (IEC and ISO), these standards cover general safety, electromagnetic compatibility, and biological evaluation, which are relevant to many types of medical and cosmetic devices that interact with the body. They don't specifically indicate an IVD function.
- Predicate Device: The predicate device (NuFace Facial Toning Device) is also a facial toning device, not an IVD.
In summary, the Ageless Wonder Facial Toning Device is designed for cosmetic facial muscle stimulation and explicitly states it is not for diagnostic purposes. This aligns with the definition of a cosmetic or general medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ageless Wonder Facial Toning Device is intended for facial stimulation and is indicated for overthe-counter cosmetic use. The anatomical site for application of the Ageless Wonder Facial Toning Device is the face.
Product codes (comma separated list FDA assigned to the subject device)
NFO
Device Description
The Ageless Wonder Facial Toning Device is a battery-powered portable EMS device. It applied specially designed bi-polar low voltage micro-current impulses on the face.
Not for use on injured or otherwise impaired skin or muscles, or use in any therapy or for the treatment, diagnosis, prevention or cure of any medical conditions or diseases. The device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper
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
personal beauty purposes / over-the-counter cosmetic 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
510(1.1)= K120511
Sponsor: Leto Enterprises Incorporation Subject Device: Ageless Wonder Facial Toning Device File No.: 510(k) submission report , Chapter 6
Chapter 6. 510(k) Summary
JUL 30 2012
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
-
- Submitter Information
Establishment Registration Name and address: Sponsor Name: Leto Enterprises Incorporation Address: 19/F, Nan Dao Commercial Bldg, 359-361 Queen's Road Central, Hong Kong, China Contact Person: Mr. CHOI CHUI NGAN (Director) Tel: (852) 3694 0110 Fax: (852) 2515 3995 Email: dir@leto-ent.com
- Submitter Information
2. Application Correspondent Information:
MEDLAB (Shenzhen) Information Service Co., Ltd. Address: Room 2706, Block A, ZhongFang JinYuan Buiding, Xinwen Road, Shenzhen, Guangdong, P.R. China, 518034 Contact Person: Ms. Sabrina Wei Tel: +86-755-8308 9699 Fax: +86-755-8632 9134 Email: sabrinawei@hotmail.com
3. Subject Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Device Common Name: | Facial Toning device |
| Trade Name: | Ageless Wonder Facial Toning Device |
| Classification Name: | Transcutaneous Electrical Nerve Stimulator |
| Review Panel: | Neurology |
| Product Code: | NFO |
| Regulation Class: | II |
| Regulation Number: | 882.5890 |
Report by MEDLAB (Shenzhen) Information Service Co., Ltd.
1
4. Predicate Device Information
| Sponsor: | Carol Cole Company |
|---|---|
| Device: | NuFace Facial Toning Device |
| 510(k) Number: | K072260 |
5. Device Description
The Ageless Wonder Facial Toning Device is a battery-powered portable EMS device. It applied specially designed bi-polar low voltage micro-current impulses on the face.
Not for use on injured or otherwise impaired skin or muscles, or use in any therapy or for the treatment, diagnosis, prevention or cure of any medical conditions or diseases. The device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper
6. Intended Use
Ageless Wonder Facial Toning Device is intended for facial stimulation and is indicated for overthe-counter cosmetic use. The anatomical site for application of the Ageless Wonder Facial Toning Device is the face.
7. Test Summary
Ageless Wonder Facial Toning Device conforms to the following standards:
- � IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995
- IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety � and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 2007
- � IEC 60601-2-10, Medical electrical equipment - Part 2-10: Particular requirements for nerve and muscle stimulators, 1987; A1, 2001
- ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a � risk management process.2009
- ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for In Vitro cytotoxicity, � 2009
- � ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity, 2010
2
Sponsor: Leto Enterprises Incorporation Ageless Wonder Facial Toning Device Subject Device: 510(k) submission report , Chapter 6 · File No.:
8. Comparison to Predicate Device
Compare with predicate device, they are very similar in design principle, intended 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 | Verdict |
|---|---|---|---|
| Product Name | Ageless Wonder Facial Toning | ||
| Device | Nuface | -- | |
| K Number | Applying | K072260 | -- |
| Product Code | NFO | NFO | SE |
| Regulation Number | 21 CFR 882.5890 | 21 CFR 882.5890 | SE |
| Intended Use and | |||
| Indications for Use | Ageless Wonder Facial Toning | ||
| Device is intended for facial | |||
| stimulation and is indicated for | |||
| over-the-counter cosmetic use. | |||
| The anatomical site for | |||
| application of the Ageless | |||
| Wonder Facial Toning Device is | |||
| the face. | The NuFace Facial Toning | ||
| Device is intended for facial | |||
| stimulation and is indicated for | |||
| over-the-counter cosmetic us. | |||
| The anatomical site for | |||
| application of the NuFace is | |||
| the face. | SE | ||
| SPECIFICATION | |||
| Patient Protection | Type BF | Type BF | SE |
| Type of Protection | |||
| against Electric | |||
| Shock | Internally powered equipment | Internally powered equipment | SE |
| Battery life | Approximately 2 hours to 3 | ||
| hours at nominal settings | Approximately 2 hours to 3 | ||
| hours at nominal settings | SE | ||
| Channel | Single Channel | Single Channel | SE |
| Current | From 0 to 43.2 uA (From 0 to | ||
| 1000 Ohm) | From 0 to 400 uA | Note 1 | |
| Pulse Width Range | 150 us | 112 ms | Note 1 |
| Display | LCD | LED | Note 2 |
| DIMENSIONS/WEIGHT | |||
| Dimensions | 98.5mm x 53mm x 27.5mm | 7cm(L)x 2.5cm(W) x 1cm(D) | Note 3 |
| Device Net Weight | 90g (including headset) | 1.8 lbs | Note 3 |
| OPERATING & STORAGE CONDITIONS | |||
| Storage | |||
| Environment | Temperature: 10°C ~ 55°C | ||
| Relative Humidity: ≤95% | |||
| Atmospheric Pressure: 500hPa | |||
| ~ 1060 hPa | None | Note 3 | |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Working | |||
| Environment | Temperature: 5°C ~ 40°C | ||
| Relative Humidity: ≤80% RH | |||
| Atmospheric Pressure: -70 kPa | |||
| ~ 106 kPa | None | Note3 | |
| Evaluation | |||
| Electrical, | |||
| Mechanical and | |||
| Thermal Evaluation | IEC 60601-1 | ||
| IEC 60601-1-2 | IEC 60601-1 | Note 1 | |
| Biocompatibility | |||
| Evaluation | All the accessories are cleared | ||
| or listing by FDA, which are | |||
| evaluated by the biocompatibility | |||
| standard ISO 10993 -5, -10. | The biocompatibility of the | ||
| accessories is evaluated as | |||
| per the requirement of the | |||
| standard ISO 10993 -5, -10. | SE | ||
| Recommendation Accessory | |||
| Heavy Duty Battery | 1.5V AAA x 2 pieces | 9-volt battery | Note 1 |
| Cable | 0.3mm | Carol Cole Derma-Gel NuFace | |
| Conductivity Gel (8.45 fl oz / | |||
| 250 ml) | Note 4 | ||
| Conductive Sponge | Thickness - 0.5mm | Carol Cole Optimizing Mist (8 fl | |
| oz / 237 ml) | Note 4 |
Report by MEDLAB (Shenzhen) Information Service Co., Ltd.
Page 6-3
3
Sponsor: Leto Enterprises Incorporation Subject Device: Ageless Wonder Facial Toning Device File No.: 510(k) submission report , Chapter 6
Note 1:
Both subject device and predicate device are complied with IEC 60601-1. The difference of their rating does not affect the safety and effectiveness.
Note 2:
The display of the subject device is LCD, while the display of predicate device is LED. But they are complied with IEC 60601-1, and they can display required information of the device.
Note 3:
Although some specifications of performance specification, dimensions/weight, operating & storage conditions are different for subject device and predicate device, they are both complied with IEC 60601-1.
Note 4:
Although some specifications for recommendation accessories of subject device and predicate device are different, they are all FDA Listing or cleared devices. The differences do not affect the safety and effectiveness.
Report by MEDLAB (Shenzhen) Information Service Co., Ltd.
4
9. Conclusion
The subject devices have all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject devices.
Thus, the subject devices are substantially equivalent to the predicate devices.
10. Summary Prepared Date
July 11th, 2012
Page 6-5
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUI 30 2012
Leto Enterprises Incorporation % Ms. Sabrina Wei Manager MEDLAB (Shenzhen) Information Service Co., Ltd. Room 2706, Block A, Jinyuan Building Xinwen Road Shenzhen, Guangdong 518034 China
Re: K120511
Trade/Device Name: Ageless Wonder Facial Muscle Stimulation System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: NFO Received: July 20, 2012
Dear Ms. Wei:
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
6
Page 2 - Ms. Sabrina Wei
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Leto Enterprises Incorporation Sponsor: Ageless Wonder Facial Muscle Știmulation System Subject Device: 510(k) submission report, Chapter 5 File No.:
Chapter 5. Statement of Indications for Use
Indications for Use
510(k) Number (if known): Applying
Device Name: Ageless Wonder Facial Muscle Stimulation System
Indications for Use:
mallette for of of of of for over-the-counter cosmetic use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ X (21 CFR 801 Subpart C)
(Please do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number K110511
Signature
Page __ 1_ of _1
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
. 510(k) Number k>v S11
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