The Sonilase Light Deviceis a modular system that offers red light therapy for the treatment of wrinkles, rhytides, and fine lines in the periorbital region. The Sonilase system components include the handheld unit containing the LED module , attachable clear plastic lens cover, an adjunct attachable cleansing brush head, recharging stand, 7.4V LI-ION BATTERY, 9V UL approved power supply , UV Sanitizing cradle and goggles. 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).

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that "proves" the device meets them, based on the provided 510(k) summary for the Sonilase Light Device Red:

Important Note: This 510(k) summary is for a light-based over-the-counter wrinkle reduction device. The "acceptance criteria" and "study" described are in the context of demonstrating substantial equivalence to a predicate device, not necessarily a rigorous clinical trial proving independent efficacy as might be seen for a novel therapeutic device. The focus here is on showing similar performance to a device already deemed safe and effective.

Acceptance Criteria and Reported Device Performance

This section is challenging to populate directly from the provided text because explicit "acceptance criteria" as pass/fail thresholds for clinical efficacy are not clearly defined or presented for this specific device. Instead, the submission relies on demonstrating technological equivalence and similar performance characteristics to a legally marketed predicate device (Tanda Max OTC System).

The "performance" described is largely focused on confirming the device operates as intended and is safe for use by laypeople, rather than clinical outcomes.

Acceptance Criteria (Inferred from comparison to predicate and testing)	Reported Device Performance
Technological Equivalence to Predicate:
Same intended use	"Has the same intended use as the predicate..."
Same output (50 mW/cm²)	"Has the same output (i.e., 50 mW/cm²) as the predicate..."
Same wavelength (660 nm)	"Utilizes the same wavelength (i.e., 660 nm) as the predicate device..."
Same treatment duration (160 seconds)	"Utilizes the same treatment duration (i.e., 160 seconds) as the predicate device..."
Same treatment regimen (twice a week for six weeks)	"Utilizes the same treatment regimen of twice a week for six weeks."
Functional & Safety Performance:
Electromagnetic Compatibility (IEC 60601-1-2)	"Complies with IEC 60601-1-2 Electromagnetic Compatibility"
Electrical Safety (IEC 60601-1-1)	"Complies with IEC 60601-1-1 Electrical Safety"
Software Validation (FDA Guidance)	"The Sonilase software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices""
Usability/Label Comprehension	100% of participants comprehended labeling; 97% used the device successfully.

Study Information

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: 38 participants for the Usability/Label Comprehension Study.
- Data Provenance: Not explicitly stated, but typically these studies are conducted in the country of submission (USA for FDA). The study is prospective in nature, as it involves active participation and observation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not directly applicable in the context of this 510(k) submission as no "ground truth" derived from expert assessment of patient outcomes for wrinkle reduction efficacy is presented or required for this type of device and submission pathway. The Usability study focuses on user comprehension and device operation, not clinical ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. The usability study involved observing participants and assessing their comprehension of labeling and ability to use the device, not adjudicating clinical observations.
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:
- No. This is not an AI-assisted device, nor is it a diagnostic imaging device where MRMC studies are typically performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical light therapy device, not an algorithm. Its performance is inherent in its physical properties and intended use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the usability study, the "ground truth" was established by observing whether participants successfully comprehended instructions and operated the device as intended. This is a form of empirical observation of user behavior against predefined success criteria for usability and comprehension.
- For the overall substantial equivalence, the "ground truth" for efficacy is implicitly the established efficacy of the predicate device (Tanda Max OTC System) for wrinkle reduction. The Sonilase device is deemed substantially equivalent because it shares the same technological characteristics (wavelength, power, treatment regimen) and intended use as the predicate.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the machine learning sense. The device's design, functional testing, and usability study are based on engineering principles and human factors, not data training.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set."

Summary

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510(k) Summary

K132613

This summary of 510(k) summary information is being submitted in accordance with the requirements of 21 CFR § 878.4810.

Submission Date: August 8, 2013

1. 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: Biorenew Labs, LLC

Attn: Jon David 415 Pier Avenue Hermosa Beach, CA 90254 Tel.: 310-400-0631 Email: jon@biorenewlabs.com

2. General Information

2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction Device

2.2 Common/Usual Name: Sonilase Light Device Red

2.3 Proprietary Names: Sonilase Light Device

2.4 Classification: Class II

2.5 Classification Number: 878.4810

2.6 Product Codes: OHS

3. Device Description:

The Sonilase Light Deviceis a modular system that offers red light therapy for the treatment of wrinkles, rhytides, and fine lines in the periorbital region.

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The Sonilase system components include the handheld unit containing the LED module , attachable clear plastic lens cover, an adjunct attachable cleansing brush head, recharging stand, 7.4V LI-ION BATTERY, 9V UL approved power supply , UV Sanitizing cradle and goggles.

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).

4. Indications / Intended Use:

The Sonilase™ Light Device is used to treat periorbital wrinkles and fine lines around the eyes

(i.e., crow's feet).

Rx or OTC:

The Sonilase Light Device 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 device is OTC.

5. Predicate Device:

This device is substantially equivalent to the following predicate device, which is currently in safe and effective commerce:

1. K110735 Tanda Max OTC System (Pharos Life Corporation)

Predicate Chart

Device	Tanda Max OTCSystem	Sonilase Red OTCSystem
	Pharos Life Corp.	Biorenew Labs, LLC
	K110735	K132613
	A Predicate Device	This Submission
Indications	The Tanda Max OTCSystem is intended to beused for the treatment ofwrinkles, rhytides, andfine lines in theperiorbital region.	The Sonilase Red OTCSystem is intended to beused for the treatment ofwrinkles, rhytides, andfine lines in theperiorbital region.
Handheld	Yes	Yes
Wavelength	660 nm	660 nm
Modes	On/Off	On/Off
Red powersource	LEDs	LEDs

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Device	Tanda Max OTCSystem	Sonilase Red OTCSystem
	Pharos Life Corp.	Biorenew Labs, LLC
	K110735	K132613
	A Predicate Device	This Submission
Visible lightLEDs	Yes	Yes
Energy Level	50 mW total	50 mW total
Power Supply	One 9v rechargeablealkaline battery	One 9v rechargeablealkaline battery
TreatmentTime	160 seconds2 days perweek for 6 weeks	160 seconds2 days perweek for 6 weeks
TargetPopulation	Individuals withperiorbital lines andwrinkles.	Individuals withperiorbital lines andwrinkles.
Location forUse	OTC	OTC

Summary of the technological characteristics of the device compared to predicate device:

Has the same intended use as the predicate (i.e., Treatment of wrinkles, rhytides and fine lines in the periorbital region;
Has the same output (i.e., 50 mW/cm2 ) as the predicate;
Utilizes the same wavelength (i.e., 660 nm) as the predicate device;
Utilizes the same treatment duration (i.e., 160 seconds) as the predicate device;
Utilizes the same treatment regimen of twice a week for six weeks.

The Sonilase Light Device and the above referenced predicate, Tanda Max OTC device, are Over the Counter Devices used to treat wrinkles as defined in 21 CFR § 878.4810. These devices utilize red diodes at 660nm to provide narrow bands of light energy to treat periorbital 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 device, the Sonilase Light Device has the same intended uses, with similar

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technological characteristics as the predicate device. The system performs as intended and does not raise any new safety or effectiveness issues.

6. Technological Characteristics

The Sonilase Light Device operates by a cordless system drawing upon its 7.4V rechargeable battery to deliver the treatment. The Sonilase Light Device delivery system used for applying therapy for the use in the treatment of periorbital wrinkles, is by emitting at least 50 mW/cm² of red (660nm) light via an electric light emitting diodes [LEDs] energy source. The device is not intended for ocular applications or direct eye exposure.

7. Performance Testing and Standards:

Testing of the Sonilase included functional performance testing, software validation testing and user safety testing.

The results of this testing are as follows:

Complies with IEC 60601-1-2 Electromagnetic Compatibility Complies with IEC 60601-1-1 Electrical Safety

The Sonilase 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/Label Comprehension Study was conducted with 38 participants. The results of the study found that: 100% of the participants were able to comprehend the labeling. 97% of the participants were able to use the device successfully.

9. Substantial Equivalence Conclusion

After an analysis of the safety, indications, intended uses, performance, design materials, power output, technological properties, treatment areas, and treatment regimes the manufacturer believes that no significant differences exist between the device and the predicate device. Therefore substantial equivalency is requested.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the words "Public Health Service" in a simple, sans-serif font. The text is black and appears to be on a white background. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Biorenew Labs, LLC % Ms. Susan Anthoney AEGIS Regulatory Incorporated 2424 Dempster Drive Coralville, Iowa 52241

Re: K132613

Trade/Device Name: Sonilase Light Device Red 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: January 5, 2013 Received: January 8, 2013

Dear Ms. Anthoney:

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.

February 5, 2014

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Susan Anthoney

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm.

For

Sincerely yours.

Joshua F.C.Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132613

Device Name Sonilase Light Device Red

Indications for Use (Describe)

The Sonilase™ Light Device Red is used to treat periorbital wrinkles and fine lines around the eyes (i.e., crow's feet).

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FDA USE ONLY ( ್ನು ಇತ್ತಿದ್ದರೆ ಕೆ ಬ Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (1/14) for BSA Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

Regulation Number and Section

§ 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.