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.

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

AI/ML Overview

The provided text describes the 510(k) summary for the "Ageless Wonder Facial Toning Device" (K120511), which is a "Transcutaneous Electrical Nerve Stimulator" for facial stimulation for cosmetic use.

However, the document does not contain acceptance criteria or details of a study that proves the device meets specific performance criteria through clinical data or algorithm-specific metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (NuFace Facial Toning Device, K072260) based on design principles, intended use, functions, materials, and compliance with general safety and electrical standards.

Here's an analysis based on the provided text, highlighting what is present and what is absent regarding your request:

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state specific acceptance criteria related to clinical performance (e.g., a certain percentage improvement in facial toning or specific electrical output levels for effectiveness). Instead, the "acceptance criteria" are implied by compliance with recognized standards and substantial equivalence to the predicate device.

Acceptance Criteria (Implied by Standards & Equivalence)	Reported Device Performance (from "Comparison to Predicate Device" table)
Compliance with IEC 60601-1 (General Safety)	Complied (Verdict: SE - Substantially Equivalent)
Compliance with IEC 60601-1-2 (EMC)	Complied (Verdict: Note 1 - Does not affect safety/effectiveness)
Compliance with IEC 60601-2-10 (Nerve & Muscle Stimulators)	Complied
Compliance with ISO 10993-1, -5, -10 (Biocompatibility)	Complied (Accessories evaluated, Verdict: SE)
Intended Use: Facial stimulation for over-the-counter cosmetic use	Ageless Wonder Facial Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (Verdict: SE)
Patient Protection (Type BF)	Type BF (Verdict: SE)
Protection against Electric Shock (Internally powered)	Internally powered equipment (Verdict: SE)
Battery life (similar to predicate)	Approximately 2-3 hours (Verdict: SE)
Channel (Single)	Single Channel (Verdict: SE)
Current (similar safety profile to predicate)	From 0 to 43.2 uA (Verdict: Note 1 - Does not affect safety/effectiveness despite difference with predicate's 0-400 uA)
Pulse Width Range (similar safety profile to predicate)	150 us (Verdict: Note 1 - Does not affect safety/effectiveness despite difference with predicate's 112 ms)
Display (functions as required)	LCD (Verdict: Note 2 - Complies with IEC 60601-1, displays required info)
Dimensions/Weight (safe and functional)	98.5mm x 53mm x 27.5mm; 90g (Verdict: Note 3 - Complies with IEC 60601-1)
Operating & Storage Conditions (defined and safe)	Temperature: 10-55°C (storage), 5-40°C (working); Humidity: <=95% RH (storage), <=80% RH (working); Atmospheric Pressure: 500-1060 hPa (storage), -70-106 kPa (working) (Verdict: Note 3 - Complies with IEC 60601-1)
Recommendation Accessory (FDA cleared/listed)	1.5V AAA x 2 batteries; 0.3mm cable; 0.5mm conductive sponge (Verdict: Note 4 - All FDA Listing or cleared devices)

Notes on the table:

"SE" (Substantially Equivalent) indicates the subject device is comparable to the predicate device in that aspect.
"Note 1", "Note 2", "Note 3", "Note 4" refer to the explanations provided in Sections 6.3 and 6.4 of the original document, primarily stating that differences do not affect safety or effectiveness, often due to continued compliance with IEC 60601-1.

Study Details

The provided document does not describe a clinical study or a study specifically designed to assess the performance of the device against specific acceptance criteria for effectiveness. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device through engineering comparisons and compliance with relevant safety and electrical standards.

Therefore, the following points cannot be answered from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable, as no performance test set or clinical study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 but a direct stimulation device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary: The 510(k) submission for the Ageless Wonder Facial Toning Device primarily establishes substantial equivalence to a predicate device (NuFace Facial Toning Device, K072260) by demonstrating similar intended use, design principles, materials, and compliance with recognized electrical and safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993 series). It does not present data from a clinical performance study with specific acceptance criteria, test set sizes, expert ground truth, or MRMC studies, as these types of studies are often not required for devices seeking 510(k) clearance based on substantial equivalence to a predicate, especially for devices like "facial toning devices" with cosmetic indications. The "acceptance criteria" are met by demonstrating that the device's characteristics are safe and effective enough to be considered substantially equivalent to a device already on the market.

Summary

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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.

1. 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

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.

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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.

6. Intended Use

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

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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 ofComparison	Subject Device	Predicate Device	Verdict
Product Name	Ageless Wonder Facial ToningDevice	Nuface	--
K Number	Applying	K072260	--
Product Code	NFO	NFO	SE
Regulation Number	21 CFR 882.5890	21 CFR 882.5890	SE
Intended Use andIndications for Use	Ageless Wonder Facial ToningDevice is intended for facialstimulation and is indicated forover-the-counter cosmetic use.The anatomical site forapplication of the AgelessWonder Facial Toning Device isthe face.	The NuFace Facial ToningDevice is intended for facialstimulation and is indicated forover-the-counter cosmetic us.The anatomical site forapplication of the NuFace isthe face.	SE
SPECIFICATION
Patient Protection	Type BF	Type BF	SE
Type of Protectionagainst ElectricShock	Internally powered equipment	Internally powered equipment	SE
Battery life	Approximately 2 hours to 3hours at nominal settings	Approximately 2 hours to 3hours at nominal settings	SE
Channel	Single Channel	Single Channel	SE
Current	From 0 to 43.2 uA (From 0 to1000 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
StorageEnvironment	Temperature: 10°C ~ 55°CRelative Humidity: ≤95%Atmospheric Pressure: 500hPa~ 1060 hPa	None	Note 3
Elements ofComparison	Subject Device	Predicate Device	Verdict
WorkingEnvironment	Temperature: 5°C ~ 40°CRelative Humidity: ≤80% RHAtmospheric Pressure: -70 kPa~ 106 kPa	None	Note3
Evaluation
Electrical,Mechanical andThermal Evaluation	IEC 60601-1IEC 60601-1-2	IEC 60601-1	Note 1
BiocompatibilityEvaluation	All the accessories are clearedor listing by FDA, which areevaluated by the biocompatibilitystandard ISO 10993 -5, -10.	The biocompatibility of theaccessories is evaluated asper the requirement of thestandard 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 NuFaceConductivity Gel (8.45 fl oz /250 ml)	Note 4
Conductive Sponge	Thickness - 0.5mm	Carol Cole Optimizing Mist (8 floz / 237 ml)	Note 4

Report by MEDLAB (Shenzhen) Information Service Co., Ltd.

Page 6-3

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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.

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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

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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

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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

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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

Report by MEDLAB (Shenzhen) Information Service Co., Ltd.

Regulation Number and Section

§ 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).